Parkinson's DiseasePhase 2NCT04506073
Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease
A Phase 2 study testing Mesenchymal Stem Cells in people with Parkinson's Disease, run by Mya Schiess at 1 site in United States.
Trial summary
The purpose of this study is to select the safest and most effective number of repeat doses of allogeneic bone marrow-derived mesenchymal stem cell (MSC) infusions to slow the progression of Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Mesenchymal Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 30 Jul 2023
- 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 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease by the UK brain bank criteria including the presence of 2 cardinal signs of PD plus bradykinesia.
- Mild microsomia to anosmia.
- A modified Hoehn and Yahr stage of 3 or less.
- Date of diagnosis of PD between 3 to 10 years
- Robust response to dopaminergic therapy.
Who cannot join
- Atypical, vascular, or drug-induced Parkinsonism.
- An atypical DAT scan or MRI supporting an alternative explanation for PD symptoms.
- Patient not on levodopa containing medications.
- Clinical features of psychosis or refractory hallucinations.
- A Montreal Cognitive Assessment (MoCA) score of less than 25.
- Uncontrolled seizure disorder.
Show all 21Show fewer
- Abnormal Kidney and liver function.
- Presence of clinically refractory orthostatic hypotension at the screening or baseline visit.
- Body mass index of greater than or equal to 35.
- Cardiac disease: History of congestive heart failure, clinically significant bradycardia, presence of 2nd, or 3rd-degree atrioventricular block.
- Pulmonary disease: COPD with oxygen-requirement at rest or with ambulation; or moderate to severe asthma.
- Active malignancy or diagnosis of malignancy within 5 years prior to the start of screening
- Any current suicidal ideation or behaviors.
- Any diagnosis of autoimmune disease or immunocompromised state
- History of medium or large size vessel cerebrovascular accidents.
- History of traumatic brain injury with loss of consciousness and residual neurologic symptoms.
- Major surgery within the previous 3 months or planned in the ensuing 6 months.
- History of use of an investigational drug within 90 days prior to the screening visit.
- History of brain surgery for PD.
- Substance abuse disorder.
- Active anticoagulation treatment and/or abnormal INR.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial of Allogeneic Bone Marrow-derived Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease
The purpose of this study is to select the safest and most effective number of repeat doses of allogeneic bone marrow-derived mesenchymal stem cell (MSC) infusions to slow the progression of Parkinson's disease (PD).
Read the detailed description
Single site phase IIa study of allogeneic MSC in a double blind randomized control trial as disease modifying therapy for PD. The design includes three treatment arms with 45 patients.
- Conditions
- Parkinson's Disease
- Being tested
- Mesenchymal Stem Cells, Placebo
- Keywords
- Stem Cells, Mesenchymal stem cells, Inflammatory markers
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem CellsDrug
Also called allogeneic mesenchymal stem cells
1 dose is 10 X 10^6 MSC/kg
PlaceboDrug
Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal Stem Cells and Placebo | Experimental | 2 infusions of 10 X 10^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart. Receives: Drug: Mesenchymal Stem Cells; Drug: Placebo |
| Mesenchymal Stem Cells | Experimental | 3 infusions of 10 X 10^6 MSC/kg administered every 4 months. Receives: Drug: Mesenchymal Stem Cells |
| Placebo | Placebo comparator | 3 placebo doses administered every 4 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayesian Mean Estimate of the Proportion of Participants Achieving a ≥5-point Improvement on MDS-UPDRS Part III From Screening to Week 62, Compared Between Each Active MSC Dose Arm and Placebo
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III assesses motor symptoms of Parkinson's disease. . A responder was defined as a participant achieving a ≥5-point improvement (decrease of at least 5 points from screening) at Week 62. Reported are the Bayesian mean estimates of the proportion of participants achieving this response. The 95% confidence interval represents the Bayesian 95% credible interval.
Measured: From Baseline to Week 62
Secondary outcomes (16)
Number of Participants With New-onset Organ Failure
New-onset organ failure defined as a significant acute change in the kidney or liver function, leukocytosis, leukopenia or anemia sustained over 3 months; > 75 % reduction in GFR compared to baseline; altered liver function as defined by ALT >150 U/L and or total bilirubin >1.6 mg/dl; or leukopenia defined as < 4K WBC count or anemia as defined by Hgb < 12 for men and < 11 for women.
Measured: Baseline through week 88
Number of Participants Developing Donor-Specific Anti-HLA Antibodies
Measured: Baseline through week 88
Motor Function as Measured by the Timed-Up-and-Go (TUG) Scale
This test uses the time that a person takes to rise from a chair, walk 7 meters, turn around, walk back to the chair, and sit down. Time is recorded in seconds, a longer duration of time indicates a worse outcome.
Measured: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Number of Participants With Lifetime Suicidal Ideation (C-SSRS)
The Columbia-Suicide Severity Rating Scale (C-SSRS) is an assessment tool that evaluates suicidal ideation and behavior. Reported is the number of participants with a positive response to the lifetime suicidal ideation question, "Have you actually had any thoughts of killing yourself?"
Measured: Baseline
Parkinson's Disease Severity as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assesses the severity of Parkinson's disease. The total score ranges from 0 to 265, with higher scores indicating greater Parkinson's disease severity and disability.
Measured: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Motor Symptoms of Parkinson's Disease as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination Score
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination assesses motor symptoms of Parkinson's disease. The total score ranges from 0 to 132, with higher scores indicating greater motor impairment and more severe Parkinson's disease motor symptoms.
Measured: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Global Measurement of Disability as Measured by the Change in the Screening "Off" Modified Hoehn and Yahr (H&Y)
The Modified Hoehn and Yahr (H\&Y) Scale described the progress of Parkinson's disease. Total score ranges from 0 to 5, with higher scores indicating a worse outcome. The assessment was performed in the "off" medication state, and the score will be reported.
Measured: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Quality of Life as Measured by the Modified Schwab and England Activities of Daily Living Scale (ADL)
The Schwab and England Activities of Daily Living (ADL) Scale assesses functional independence in individuals with Parkinson's disease. Scores range from 0% to 100%, with higher percentages indicating greater independence and better functional ability in activities of daily living.
Measured: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Quality of Life as Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39)
The Parkinson's Disease Questionnaire-39 (PDQ-39) assesses health-related quality of life in individuals with Parkinson's disease. Total scores range from 0 to 100, with higher scores indicating poorer quality of life.
Measured: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Quality of Life as Measured by the EuroQol- 5 Dimension (EQ-5D) Index Score
The EuroQol- 5 Dimension (EQ-5D) assesses quality of life. The total score ranges between 0 to 1, a higher score indicating better quality of life.
Measured: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Non- Motor Symptoms as Measured by the Non-Motor Symptoms Questionnaire (NMSQ)
The Non-Motor Symptoms Questionnaire (NMSQ) assesses the presence of non-motor symptoms associated with Parkinson's disease. Total score ranges from 0 to 30, with a higher score indicating a greater number of non-motor symptoms.
Measured: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Olfactory Function as Assessed by the University of Pennsylvania Smell Identification Test (UPSIT-40) Score
The University of Pennsylvania Smell Identification Test (UPSIT-40) assesses olfactory function. The total score ranges from 0 to 40 with a higher score indicating better olfactory function.
Measured: Baseline, Week 49, Week 88
Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) assesses cognitive function. The total score ranges from 0 to 30, a higher score indicates better cognitive function.
Measured: Baseline, Week 49, Week 88
Anxiety as Assessed by the Parkinson Anxiety Scale (PAS) Score
The Parkinson Anxiety Scale (PAS) assesses anxiety symptoms in individuals with Parkinson's disease. The total score ranges from 0 to 48, with higher scores indicating greater anxiety severity.
Measured: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Depressive Symptoms as Assessed by the Geriatric Depression Scale-Short Form (GDS-SF) Score
The Geriatric Depression Scale-Short Form (GDS-SF) assesses depressive symptoms. The total score ranges from 0 to 15, with higher scores indicating greater depressive symptom severity.
Measured: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Number of Participants Reporting Suicidal Ideation Since Last Visit
The Columbia-Suicide Severity Rating Scale (C-SSRS) assesses suicidal ideation and behavior. Reported is the number of participants with a positive response to the suicidal ideation question, "Have you actually had any thoughts of killing yourself?" since the previous study visit.
Measured: Week 9, Week 27, Week 49, Week 62, Week 88
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start9 Nov 2020
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mya Schiess
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor-investigator, Mya Schiess, The University of Texas Health Science Center, Houston
- Investigators
- Mya C Schiess, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506073
- Sponsor's protocol ID
- HSC-MS-20-0150
- Status last verified
- Aug 2026
- First submitted
- 16 Jul 2020
- Last updated
- 2 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dorsey ER, Sherer T, Okun MS, Bloem BR. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis. 2018;8(s1):S3-S8. doi: 10.3233/JPD-181474.
PubMed 30584159Braak H, Del Tredici K, Rub U, de Vos RA, Jansen Steur EN, Braak E. Staging of brain pathology related to sporadic Parkinson's disease. Neurobiol Aging. 2003 Mar-Apr;24(2):197-211. doi: 10.1016/s0197-4580(02)00065-9.
PubMed 12498954Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014 Apr 23-30;311(16):1670-83. doi: 10.1001/jama.2014.3654.
PubMed 24756517Jellinger KA. Basic mechanisms of neurodegeneration: a critical update. J Cell Mol Med. 2010 Mar;14(3):457-87. doi: 10.1111/j.1582-4934.2010.01010.x. Epub 2010 Jan 11.
PubMed 20070435Kortekaas R, Leenders KL, van Oostrom JC, Vaalburg W, Bart J, Willemsen AT, Hendrikse NH. Blood-brain barrier dysfunction in parkinsonian midbrain in vivo. Ann Neurol. 2005 Feb;57(2):176-9. doi: 10.1002/ana.20369.
PubMed 15668963Gray MT, Woulfe JM. Striatal blood-brain barrier permeability in Parkinson's disease. J Cereb Blood Flow Metab. 2015 May;35(5):747-50. doi: 10.1038/jcbfm.2015.32. Epub 2015 Mar 11.
PubMed 25757748Orr CF, Rowe DB, Halliday GM. An inflammatory review of Parkinson's disease. Prog Neurobiol. 2002 Dec;68(5):325-40. doi: 10.1016/s0301-0082(02)00127-2.
PubMed 12531233Nagatsu T, Mogi M, Ichinose H, Togari A. Cytokines in Parkinson's disease. J Neural Transm Suppl. 2000;(58):143-51.
PubMed 11128604Stypula G, Kunert-Radek J, Stepien H, Zylinska K, Pawlikowski M. Evaluation of interleukins, ACTH, cortisol and prolactin concentrations in the blood of patients with parkinson's disease. Neuroimmunomodulation. 1996 Mar-Jun;3(2-3):131-4. doi: 10.1159/000097237.
PubMed 8945728Joyce N, Annett G, Wirthlin L, Olson S, Bauer G, Nolta JA. Mesenchymal stem cells for the treatment of neurodegenerative disease. Regen Med. 2010 Nov;5(6):933-46. doi: 10.2217/rme.10.72.
PubMed 21082892Martinez-Lemus JD, Molony DA, Suescun J, Tharp E, Thomas TS, Green C, Onuigbo C, Ritter R 3rd, Schiess MC. Allogeneic bone marrow-derived mesenchymal stem cells in the aging kidney: secondary results of a Parkinson's disease clinical trial. Stem Cell Res Ther. 2025 Sep 24;16(1):493. doi: 10.1186/s13287-025-04577-y.
PubMed 40993774
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial of Allogeneic Bone Marrow-derived Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04506073
- Acronym / sponsor ID
- HSC-MS-20-0150
- Conditions
- Parkinson's Disease
- Keywords
- Stem Cells, Mesenchymal stem cells, Inflammatory markers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mya SchiessUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Posted 2 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to select the safest and most effective number of repeat doses of allogeneic bone marrow-derived mesenchymal stem cell (MSC) infusions to slow the progression of Parkinson's disease (PD).
Detailed description
Single site phase IIa study of allogeneic MSC in a double blind randomized control trial as disease modifying therapy for PD. The design includes three treatment arms with 45 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal Stem Cells and Placebo | Experimental | Drug: Mesenchymal Stem Cells, Drug: Placebo2 infusions of 10 X 10^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart. |
| Mesenchymal Stem Cells | Experimental | Drug: Mesenchymal Stem Cells3 infusions of 10 X 10^6 MSC/kg administered every 4 months. |
| Placebo | Placebo comparator | Drug: Placebo3 placebo doses administered every 4 months. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Parkinson's disease by the UK brain bank criteria including the presence of 2 cardinal signs of PD plus bradykinesia.
- Mild microsomia to anosmia.
- A modified Hoehn and Yahr stage of 3 or less.
- Date of diagnosis of PD between 3 to 10 years
- Robust response to dopaminergic therapy.
Key exclusion criteria (21 listed)
- Atypical, vascular, or drug-induced Parkinsonism.
- An atypical DAT scan or MRI supporting an alternative explanation for PD symptoms.
- Patient not on levodopa containing medications.
- Clinical features of psychosis or refractory hallucinations.
- A Montreal Cognitive Assessment (MoCA) score of less than 25.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal Stem CellsAlso: allogeneic mesenchymal stem cells1 dose is 10 X 10^6 MSC/kg | Drug | Mesenchymal Stem Cells, Mesenchymal Stem Cells and Placebo |
| PlaceboPlacebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs). | Drug | Mesenchymal Stem Cells and Placebo, Placebo |
Primary outcome
Bayesian Mean Estimate of the Proportion of Participants Achieving a ≥5-point Improvement on MDS-UPDRS Part III From Screening to Week 62, Compared Between Each Active MSC Dose Arm and Placebo
Time frame: From Baseline to Week 62
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III assesses motor symptoms of Parkinson's disease. . A responder was defined as a participant achieving a ≥5-point improvement (decrease of at least 5 points from screening) at Week 62. Reported are the Bayesian mean estimates of the proportion of participants achieving this response. The 95% confidence interval represents the Bayesian 95% credible interval.
16 secondary outcomes
Number of Participants With New-onset Organ Failure
Time frame: Baseline through week 88
Number of Participants Developing Donor-Specific Anti-HLA Antibodies
Time frame: Baseline through week 88
Motor Function as Measured by the Timed-Up-and-Go (TUG) Scale
Time frame: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Number of Participants With Lifetime Suicidal Ideation (C-SSRS)
Time frame: Baseline
Parkinson's Disease Severity as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
Time frame: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Motor Symptoms of Parkinson's Disease as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination Score
Time frame: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Global Measurement of Disability as Measured by the Change in the Screening "Off" Modified Hoehn and Yahr (H&Y)
Time frame: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Quality of Life as Measured by the Modified Schwab and England Activities of Daily Living Scale (ADL)
Time frame: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Quality of Life as Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39)
Time frame: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Quality of Life as Measured by the EuroQol- 5 Dimension (EQ-5D) Index Score
Time frame: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Non- Motor Symptoms as Measured by the Non-Motor Symptoms Questionnaire (NMSQ)
Time frame: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Olfactory Function as Assessed by the University of Pennsylvania Smell Identification Test (UPSIT-40) Score
Time frame: Baseline, Week 49, Week 88
Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, Week 49, Week 88
Anxiety as Assessed by the Parkinson Anxiety Scale (PAS) Score
Time frame: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Depressive Symptoms as Assessed by the Geriatric Depression Scale-Short Form (GDS-SF) Score
Time frame: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88
Number of Participants Reporting Suicidal Ideation Since Last Visit
Time frame: Week 9, Week 27, Week 49, Week 62, Week 88
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30584159Dorsey ER, Sherer T, Okun MS, Bloem BR. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis. 2018;8(s1):S3-S8. doi: 10.3233/JPD-181474.
- Background: PubMed 12498954Braak H, Del Tredici K, Rub U, de Vos RA, Jansen Steur EN, Braak E. Staging of brain pathology related to sporadic Parkinson's disease. Neurobiol Aging. 2003 Mar-Apr;24(2):197-211. doi: 10.1016/s0197-4580(02)00065-9.
- Background: PubMed 24756517Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014 Apr 23-30;311(16):1670-83. doi: 10.1001/jama.2014.3654.
- Background: PubMed 20070435Jellinger KA. Basic mechanisms of neurodegeneration: a critical update. J Cell Mol Med. 2010 Mar;14(3):457-87. doi: 10.1111/j.1582-4934.2010.01010.x. Epub 2010 Jan 11.
- Background: PubMed 15668963Kortekaas R, Leenders KL, van Oostrom JC, Vaalburg W, Bart J, Willemsen AT, Hendrikse NH. Blood-brain barrier dysfunction in parkinsonian midbrain in vivo. Ann Neurol. 2005 Feb;57(2):176-9. doi: 10.1002/ana.20369.
- Background: PubMed 25757748Gray MT, Woulfe JM. Striatal blood-brain barrier permeability in Parkinson's disease. J Cereb Blood Flow Metab. 2015 May;35(5):747-50. doi: 10.1038/jcbfm.2015.32. Epub 2015 Mar 11.
- Background: PubMed 12531233Orr CF, Rowe DB, Halliday GM. An inflammatory review of Parkinson's disease. Prog Neurobiol. 2002 Dec;68(5):325-40. doi: 10.1016/s0301-0082(02)00127-2.
- Background: PubMed 11128604Nagatsu T, Mogi M, Ichinose H, Togari A. Cytokines in Parkinson's disease. J Neural Transm Suppl. 2000;(58):143-51.
- Background: PubMed 8945728Stypula G, Kunert-Radek J, Stepien H, Zylinska K, Pawlikowski M. Evaluation of interleukins, ACTH, cortisol and prolactin concentrations in the blood of patients with parkinson's disease. Neuroimmunomodulation. 1996 Mar-Jun;3(2-3):131-4. doi: 10.1159/000097237.
- Background: PubMed 21082892Joyce N, Annett G, Wirthlin L, Olson S, Bauer G, Nolta JA. Mesenchymal stem cells for the treatment of neurodegenerative disease. Regen Med. 2010 Nov;5(6):933-46. doi: 10.2217/rme.10.72.
- Derived from this study: PubMed 40993774Martinez-Lemus JD, Molony DA, Suescun J, Tharp E, Thomas TS, Green C, Onuigbo C, Ritter R 3rd, Schiess MC. Allogeneic bone marrow-derived mesenchymal stem cells in the aging kidney: secondary results of a Parkinson's disease clinical trial. Stem Cell Res Ther. 2025 Sep 24;16(1):493. doi: 10.1186/s13287-025-04577-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mya C Schiess, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal Stem Cells in people with Parkinson's Disease, run by Mya Schiess 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 5 inclusion and 21 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 2 Sep 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 2 Sep 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?
Bayesian Mean Estimate of the Proportion of Participants Achieving a ≥5-point Improvement on MDS-UPDRS Part III From Screening to Week 62, Compared Between Each Active MSC Dose Arm and Placebo (time frame: From Baseline to Week 62). 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 NCT04506073, which also lists 11 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 2 Sep 2026.