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Parkinson DiseasePhase 2NCT04995081

Clinical Trial for Parkinson's Disease Using Allogeneic HB-adMSCs (Early and Moderate PD)

A Phase 2 study testing Biological/Vaccine: Allogeneic HB-adMSCs in people with Parkinson Disease, run by Hope Biosciences Research Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, single center, phase 2 study to assess efficacy and safety of multiple allogeneic HB-adMSCs vs Placebo for the treatment of Parkinson's disease. Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Biological/Vaccine: Allogeneic HB-adMSCs
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
16 Jul 2021to 3 Oct 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A study participant will be eligible for inclusion in this study only if all the following criteria apply:
  • Male and female participants 45 - 80 years of age.
  • At the screening visit, study participants must have an MDS-UPDRS part II score between 7 and 28.
  • Study participants must have an MDS-UPDRS part III score between 20 and 57 during the screening visit.
  • Carbidopa/Levodopa total dosage must be less than 1200 mg per day for study participants.
  • The total Levodopa equivalent dose for study participants must be less than 1400 mg per day.
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  • Study participant must have been diagnosed with early and/or moderate Parkinson's disease at least 2 years prior study participation.
  • Study participants should be able to read, understand and to provide written consent.
  • Voluntarily signed informed consent obtained before any clinical-trial related procedures are performed.
  • Female study participants should not be pregnant or plan to become pregnant during study participation and for 6 months after last investigational product administration.
  • Male participants if their sexual partners can become pregnant should use a method of contraception during study participation and for 6 months after the last administration of the investigated product.
  • Study participant is able and willing to comply with the requirements of this clinical trial.

Who cannot join

  • A study participant will not be eligible for inclusion in this clinical trial if any of the following criteria apply:
  • Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take effective contraceptive measures.
  • Study participants with advanced Parkinson's disease described as, severe disability, wheelchair bound or bedridden.
  • Study participant has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.
  • Study participant has known alcoholic addiction or dependency or has current substance use or abuse.
  • Study participant has 1 or more significant concurrent medical conditions (verified by medical records), including the following:
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  • Poorly controlled diabetes mellitus (PCDM) defined as history of deficient standard of care treatment and/or pre-prandial glucose >130mg/dl during screening visit or post-prandial glucose >200mg/dl.
  • Medical History of Chronic kidney disease (CKD) diagnosis and/or screening results of eGFR < 59mL/min/1.73m2.
  • Presence of New York Heart Association (NYHA) Class III/IV heart failure during screening visit.
  • Any medical history of myocardial infarction in any of the different types, such as ST-elevation myocardial infarction (STEMI) or non-ST-elevated myocardial infarction (NSTEMI), coronary spasm, or unstable angina.
  • Medical history of uncontrolled high blood pressure defined as a deficient standard of care treatment and/or blood pressure > 180/120 mm/Hg during screening visit.
  • Medical history of inherited thrombophilias, recent major general surgery, (within 12 months before the Screening), lower extremity paralysis due to spinal cord injury, fracture of the pelvis, hips or femur, cancer of the lung, brain, lymphatic, gynecologic system (ovary or uterus), or gastrointestinal tract (like pancreas or stomach).
  • History of brain surgery for Parkinson's disease.
  • Study participant has received any stem cell treatment within 6 months before first dose of investigational product other than stem cells produced by Hope Biosciences.
  • Receiving any investigational therapy or any approved therapy for investigational use within 1 year prior first dose of the investigational product other than COVID-19 vaccines.
  • Study participant has a laboratory abnormality during screening, including the following:
  • White blood cell count < 3000/mm3
  • Platelet count < 80,000mm3
  • Absolute neutrophil count < 1500/mm3
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 10 upper limit of normal (ULN) x 1.5
  • Study participant has any other laboratory abnormality or medical condition which, in the opinion of the investigator, poses a safety risk or will prevent the subject from completing the study.
  • Study participant is unlikely to complete the study or adhere to the study procedures.
  • Study participant with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection.
  • Study participant has a previously diagnosed psychiatric condition which in the opinion of the investigator may affect self-assessments.
  • Study participant with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.
  • Male study participants who plan to donate sperm during the study or within 6 months after the last dose. Female patients who plan to donate eggs or undergo in vitro fertilization treatment during the study or within 6 months after the last dose.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hope Biosciences Stem Cell Research Foundation

    Sugar Land, Texas, 77478

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of Allogeneic HB-adMSCs vs Placebo for the Treatment of Patients With Parkinson's Disease

This is a randomized, double-blind, single center, phase 2 study to assess efficacy and safety of multiple allogeneic HB-adMSCs vs Placebo for the treatment of Parkinson's disease.

Read the detailed description

The trial includes a screening period of up to 4 weeks, a 32- week treatment period, and a safety Follow-up period of 20 weeks after the last investigational product administration.

This clinical trial will be open to enroll 60 eligible participants diagnosed with Parkinson's disease. Patients' recruitment will be conducted by the study team, if eligible participants are identified based on eligibility criteria, a screening visit will be scheduled. Informed consent form will be given to the study participants and signed before any study procedures. Informed consent form will include information about the clinical trial and some aspects should be considered during this process.

After Informed consent has been obtained, each participant should complete the following visits.

  • Visit 1 - Screening, during this visit, the principal investigator will make the decision to determine whether the screened participant is eligible and whether the next visit can be scheduled. Once, the principal investigator has evaluated the eligibility of the subject screened (up to 28 days), a randomization process will be conducted in order to assign the eligible subject either allogeneic HB-adMSCs or placebo. Randomization will only apply to eligible subjects. If a study participant does not meet the inclusion and exclusion criteria during the screening process, he/she will be considered Screen Failure (SF) and randomization is not required.
  • Visit 2 - Infusion 1, (Baseline): this visit will be used as a starting point for comparison of participant's data. During this visit, eligible study participants will receive his/her first investigational product administration or placebo with monitoring of vital signs for a total of 2 hours after drug exposure. Other study evaluations will be completed as part of this visit.
  • Visit 3 - Infusion 2: approximately 4 weeks after the initial investigational product administration this visit should be completed. Other study evaluations will be completed as part of this visit.
  • Visit 4 - Infusion 3: approximately 8 weeks after the initial investigational product administration this visit should be completed. Other study evaluations will be completed as part of this visit.
  • Visit 5 - Infusion 4: approximately 12 weeks after the initial investigational product administration this visit should be completed. Other study evaluations will be completed as part of this visit.
  • Visit 6 - Infusion 5: approximately 16 weeks after the initial investigational product administration this visit should be completed. Other study evaluations will be completed as part of this visit.
  • Visit 7 - Infusion 6: approximately 20 weeks after the initial investigational product administration this visit should be completed. Other study evaluations will be completed as part of this visit.
  • Phone Call - Safety Follow Up: approximately 24 weeks after the initial investigational product administration, active study participants will complete a phone call follow up.
  • Phone Call - Safety Follow Up: approximately 32 weeks after the initial investigational product administration, active study participants will complete a phone call follow up.
  • Visit 8 - End of Study, during this final visit (approximately 52 weeks after Week 0) a complete group of study assessments will be performed to evaluate the safety and efficacy of allogeneic HB-adMSCs or Placebo administrations.
Being tested
Biological/Vaccine: Allogeneic HB-adMSCs, Placebo
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological/Vaccine: Allogeneic HB-adMSCsBiological

    Also called Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.

    HB-adMSCs will be administered intravenously to study participants who qualify.

  • PlaceboOther

    Also called Placebo will be administered intravenously to study participants who qualify.

    Sterile Saline Solution 0.9%

Study groups in NCT04995081
Study groupRoleWhat they receive
Allogeneic HB-adMSCs.Active comparatorBiological/Vaccine: Allogeneic HB-adMSCs Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify. Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
Receives: Biological: Biological/Vaccine: Allogeneic HB-adMSCs; Other: Placebo
PlaceboPlacebo comparatorPlacebo will be administered intravenously to study participants who qualify. Other Names: Sterile Saline Solution 0.9%
Receives: Biological: Biological/Vaccine: Allogeneic HB-adMSCs; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in MDS-UPDRS Part III Total Score

    Clinically significant changes in MDS-UPDRS Part III. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  2. Change From Baseline in MDS-UPDRS Part III (Statistical Analysis - RMA Model)

    Clinically significant changes in MDS-UPDRS Part III. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  3. Change From Baseline in MDS-UPDRS Part III (Bayesian Statistical Analysis - RMA Model)

    Clinically significant changes in MDS-UPDRS Part III. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  4. Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week

    The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  5. Change From Baseline in MDS-UPDRS Part II Total Score

    Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity.

    There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  6. Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model)

    Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity.

    There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  7. Change From Baseline in MDS-UPDRS Part II (Bayesian Statistical Analysis - RMA Model)

    Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity.

    There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  8. Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week

    The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

Secondary outcomes (79)

  1. Change From Baseline in MDS-UPDRS Part I Total Score

    The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue.

    There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  2. Change From Baseline in MDS-UPDRS Part I (Statistical Analysis - RMA Model)

    The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue.

    There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  3. Change From Baseline in MDS-UPDRS Part I (Bayesian Statistical Analysis - RMA Model)

    The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue.

    There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  4. Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week

    The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue.

    There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  5. Change From Baseline in MDS-UPDRS Part IV Total Score

    Clinically significant changes in MDS-UPDRS Part IV. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  6. Change From Baseline in MDS-UPDRS Part IV Total Score (Statistical Analysis - RMA Model)

    Clinically significant changes in MDS-UPDRS Part IV. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  7. Change From Baseline in MDS-UPDRS Part IV Total Score (Bayesian Statistical Analysis - RMA Model)

    Clinically significant changes in MDS-UPDRS Part IV. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  8. Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week

    The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

    Measured: Baseline to Weeks 52

  9. Change From Baseline in SF-36 (Average General Health) Total Score

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  10. Change From Baseline in SF-36 (Average Physical Functioning) Total Score

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  11. Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  12. Change From Baseline in SF-36 (Average Social Functioning) Total Score

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  13. Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  14. Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  15. Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  16. Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  17. Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  18. Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  19. Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  20. Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  21. Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  22. Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  23. Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  24. Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  25. Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  26. Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  27. Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  28. Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  29. Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  30. Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  31. Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  32. Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model)

    The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health.

    Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are:

    Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100

    Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.

    Measured: Baseline to Weeks 52

  33. Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores

    The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients. It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function. It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect. There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points). The PFS-16 score ranges from 16 (minimum) to 80 (maximum). Higher scores represent a worse outcome.

    Measured: Baseline to Weeks 52

  34. Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model)

    Clinically significant changes in PFS-16 scores. The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients. It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function. It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect. There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points). The PFS-16 score ranges from 16 (minimum) to 80 (maximum). Higher scores represent a worse outcome.

    Measured: Baseline to Weeks 52

  35. Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model)

    Clinically significant changes in PFS-16 scores. The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients. It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function. It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect. There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points). The PFS-16 score ranges from 16 (minimum) to 80 (maximum). Higher scores represent a worse outcome.

    Measured: Baseline to Weeks 52

  36. Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores

    Clinically significant changes in PDQ-39 SI raw scores. The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome.

    Measured: Baseline to Weeks 52

  37. Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model)

    Clinically significant changes in PDQ-39 SI raw scores. The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome.

    Measured: Baseline to Weeks 52

  38. Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model)

    Clinically significant changes in PDQ-39 SI raw scores. The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome.

    Measured: Baseline to Weeks 52

  39. Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week

    The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome.

    Measured: Baseline to Weeks 52

  40. Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores

    Clinically significant changes in VAS Pain raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes.

    Measured: Baseline to Weeks 52

  41. Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Statistical Analysis - RMA Model)

    Clinically significant changes in VAS Pain raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes.

    Measured: Baseline to Weeks 52

  42. Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Bayesian Statistical Analysis - RMA Model)

    Clinically significant changes in VAS Pain raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes.

    Measured: Baseline to Weeks 52

  43. Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Raw Scores

    Clinically significant changes in VAS Muscle Spasm raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas. The patient marks a point on the line corresponding to their muscle spasm intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes.

    Measured: Baseline to Weeks 52

  44. Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Statistical Analysis - RMA Model)

    Clinically significant changes in VAS Muscle Spasm raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas. The patient marks a point on the line corresponding to their muscle spasm intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes.

    Measured: Baseline to Weeks 52

  45. Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Bayesian Statistical Analysis - RMA Model)

    Clinically significant changes in VAS Muscle Spasm raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas. The patient marks a point on the line corresponding to their muscle spasm intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes.

    Measured: Baseline to Weeks 52

  46. Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week

    The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" in the Pain section and "No muscle spasm" and "worst muscle spasm" in the Muscle Spasm section, used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm for each section. The total score is achieved by summing the two individual scores. Higher scores represent worse outcomes.

    Measured: Baseline to Weeks 52

  47. Summary of PD Medication Dose Changes by Visit

    The following table depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints. The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints.

    Measured: Baseline to Weeks 52

  48. Summary of PD Medication Reinstatement by Visit

    The table prior to this one depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints. This table depicts the count of participants that reinstated their dose of Parkinson's disease medications after decreasing it throughout the clinical trial. The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints.

    Measured: Baseline to Weeks 52

  49. Treatment Emergent Adverse Events (Subjects With >= 1 Adverse Event) - Summary - Safety Analysis Set

    Unit (# of participants) - Treatment emergent Adverse events (Subjects with >= 1 adverse event) - Summary - Safety analysis set. Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).

    Measured: Baseline to Week 24

  50. Treatment Emergent Adverse Events (Serious AEs) - Summary - Safety Analysis Set

    Unit (# of participants) - Treatment emergent Adverse events (Serious AEs) - Summary - Safety analysis set. Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).

    Measured: Baseline to Week 24

  51. Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]

    Unit (x10^9 cells/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  52. Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]

    Unit (%) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  53. Change From Baseline Laboratory Values - CBC (g/dL) [Time Frame: Baseline to Week 52]

    Unit (g/dL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  54. Change From Baseline Laboratory Values - CBC (pg) [Time Frame: Baseline to Week 52]

    Unit (pg) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  55. Change From Baseline Laboratory Values - CBC (fL) [Time Frame: Baseline to Week 52]

    Unit (fL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  56. Change From Baseline Laboratory Values - CBC (10^12/L) [Time Frame: Baseline to Week 52]

    Unit (10^12/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  57. Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]

    Unit (g/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  58. Change From Baseline Laboratory Values - CMP (Ratio) [Time Frame: Baseline to Week 52]

    Unit (Ratio) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  59. Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]

    Unit (IU/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  60. Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]

    Unit (mg/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  61. Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]

    Unit (mmol/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  62. Change From Baseline Laboratory Values - CMP (mL/Min/1.73 m^2) [Time Frame: Baseline to Week 52]

    Unit (mL/min/1.73 m^2) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  63. Change From Baseline Laboratory Values - Coagulation Panel (Ratio) [Time Frame: Baseline to Week 52]

    Unit (Ratio) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  64. Change From Baseline Laboratory Values - Coagulation Panel (Sec.) [Time Frame: Baseline to Week 52]

    Unit (sec.) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  65. Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg)

    Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  66. Change From Baseline in Vital Signs (Heart Rate - Beats/Min)

    Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  67. Change From Baseline in Vital Signs (Oxygen Saturation - %)

    Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  68. Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min)

    Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  69. Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg)

    Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  70. Change From Baseline in Vital Signs (Temperature - Celsius)

    Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  71. Change From Baseline in Vital Signs (Weight - kg)

    Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set

    Measured: Baseline to Weeks 52

  72. Physical Examination - by Treatment Week - Abdomen

    Physical examination - by treatment week - Summary - Safety analysis set

    Measured: Baseline to Weeks 52

  73. Physical Examination - by Treatment Week - Cardiovascular

    Physical examination - by treatment week - Summary - Safety analysis set

    Measured: Baseline to Weeks 52

  74. Physical Examination - by Treatment Week - HEENT

    Physical examination - by treatment week - Summary - Safety analysis set - Head, Eyes, Ears, Nose, and Throat

    Measured: Baseline to Weeks 52

  75. Physical Examination - by Treatment Week - Lymph Node

    Physical examination - by treatment week - Summary - Safety analysis set

    Measured: Baseline to Weeks 52

  76. Physical Examination - by Treatment Week - Musculoskeletal

    Physical examination - by treatment week - Summary - Safety analysis set

    Measured: Baseline to Weeks 52

  77. Physical Examination - by Treatment Week - Neurological

    Physical examination - by treatment week - Summary - Safety analysis set

    Measured: Baseline to Weeks 52

  78. Physical Examination - by Treatment Week - Respiratory

    Physical examination - by treatment week - Summary - Safety analysis set

    Measured: Baseline to Weeks 52

  79. Physical Examination - by Treatment Week - Skin

    Physical examination - by treatment week - Summary - Safety analysis set

    Measured: Baseline to Weeks 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2021
  2. Study start16 Jul 2021
  3. Primary completion3 Oct 2025
  4. Study completion3 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A parallel study is a type of clinical study where two groups of treatments, A (allogeneic HB-adMSCs) and B (Placebo), are given so that one group receives only A while another group receives only B.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04995081
Sponsor's protocol ID
HBPD04
Status last verified
May 2026
First submitted
16 Jul 2021
Last updated
10 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cuenca L, Gil-Martinez AL, Cano-Fernandez L, Sanchez-Rodrigo C, Estrada C, Fernandez-Villalba E, Herrero MT. Parkinson's disease: a short story of 200 years. Histol Histopathol. 2019 Jun;34(6):573-591. doi: 10.14670/HH-18-073. Epub 2018 Dec 12.

    PubMed 30540129

  • Goetz CG. The history of Parkinson's disease: early clinical descriptions and neurological therapies. Cold Spring Harb Perspect Med. 2011 Sep;1(1):a008862. doi: 10.1101/cshperspect.a008862.

    PubMed 22229124

  • Stoker TB, Greenland JC, editors. Parkinson's Disease: Pathogenesis and Clinical Aspects [Internet]. Brisbane (AU): Codon Publications; 2018 Dec 21. Available from http://www.ncbi.nlm.nih.gov/books/NBK536721/

    PubMed 30702835

  • Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.

    PubMed 25904081

  • Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360.

    PubMed 32044947

  • Tambasco N, Romoli M, Calabresi P. Levodopa in Parkinson's Disease: Current Status and Future Developments. Curr Neuropharmacol. 2018;16(8):1239-1252. doi: 10.2174/1570159X15666170510143821.

    PubMed 28494719

  • Marsden CD. Problems with long-term levodopa therapy for Parkinson's disease. Clin Neuropharmacol. 1994;17 Suppl 2:S32-44.

    PubMed 9358193

  • Coppin L, Sokal E, Stephenne X. Thrombogenic Risk Induced by Intravascular Mesenchymal Stem Cell Therapy: Current Status and Future Perspectives. Cells. 2019 Sep 27;8(10):1160. doi: 10.3390/cells8101160.

    PubMed 31569696

  • Tatsumi K, Ohashi K, Matsubara Y, Kohori A, Ohno T, Kakidachi H, Horii A, Kanegae K, Utoh R, Iwata T, Okano T. Tissue factor triggers procoagulation in transplanted mesenchymal stem cells leading to thromboembolism. Biochem Biophys Res Commun. 2013 Feb 8;431(2):203-9. doi: 10.1016/j.bbrc.2012.12.134. Epub 2013 Jan 9.

    PubMed 23313481

  • Musial-Wysocka A, Kot M, Majka M. The Pros and Cons of Mesenchymal Stem Cell-Based Therapies. Cell Transplant. 2019 Jul;28(7):801-812. doi: 10.1177/0963689719837897. Epub 2019 Apr 24.

    PubMed 31018669

  • Garretti F, Agalliu D, Lindestam Arlehamn CS, Sette A, Sulzer D. Autoimmunity in Parkinson's Disease: The Role of alpha-Synuclein-Specific T Cells. Front Immunol. 2019 Feb 25;10:303. doi: 10.3389/fimmu.2019.00303. eCollection 2019.

    PubMed 30858851

  • Meirelles Lda S, Fontes AM, Covas DT, Caplan AI. Mechanisms involved in the therapeutic properties of mesenchymal stem cells. Cytokine Growth Factor Rev. 2009 Oct-Dec;20(5-6):419-27. doi: 10.1016/j.cytogfr.2009.10.002. Epub 2009 Nov 18.

    PubMed 19926330

  • Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ. 2005 Feb 1;172(3):367-79. doi: 10.1503/cmaj.1040752.

    PubMed 15684121

  • Tan EK, Chao YX, West A, Chan LL, Poewe W, Jankovic J. Parkinson disease and the immune system - associations, mechanisms and therapeutics. Nat Rev Neurol. 2020 Jun;16(6):303-318. doi: 10.1038/s41582-020-0344-4. Epub 2020 Apr 24.

    PubMed 32332985

  • Dimarino AM, Caplan AI, Bonfield TL. Mesenchymal stem cells in tissue repair. Front Immunol. 2013 Sep 4;4:201. doi: 10.3389/fimmu.2013.00201.

    PubMed 24027567

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biological/Vaccine: Allogeneic HB-adMSCs in people with Parkinson Disease, run by Hope Biosciences Research Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in MDS-UPDRS Part III Total Score (time frame: Baseline to Weeks 52). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04995081, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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