Atypical ParkinsonismPhase 1/2SO-ASC-INIVATNCT06858254
Standard Optimization of Stem Cells in Parkinson's Disease and Atypical Parkinsonism
A Phase 1/2 study testing Autologous mesenchymal stem cells in people with Atypical Parkinsonism and Parkinson Disease (PD), run by Apeiron Research Center.
Trial summary
The purpose of this study is to measure outcomes using intranasal and intravenous autologous bone marrow mesenchymal stem cells (BM-MSCs) for Parkinson Disease (PD) and Parkinson's Plus (PPS) patients. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Atypical Parkinsonism, Parkinson Disease (PD)
- What is being tested?
- Autologous mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Other non-PD/PPS Parkinsonism (e.g., drug-induced, vascular parkinsonism)
- No strong familial history of PD/PPS not attributable to environmental exposure or any known genetic predisposition to PD/PPS
- Unable to receive/tolerate neuroimaging (e.g., MRI-incompatible cardiac pacemaker)
- Unable to maintain/tolerate supine position with cervical neck extension
- Active systemic infection or local infection near the lumbar pelvis region
- Any bone marrow aspiration from the pelvis within 6 months of initial screening
Show all 34Show fewer
- Any musculoskeletal-pelvis contraindications to BMA harvest from the PSIS
- Concurrent enrollment in another PD/PPS study or having taken/received another investigational intervention within 6 weeks of initial screening
- Malignancy diagnosed </= 2 years prior to initial screening
- History of intracranial or nasopharyngeal surgery deemed detrimental to the participant during the trial, including brain surgery/stereotactic procedure for PD/PPS
- History of electroconvulsive therapy
- Chronic Kidney Disorder (CKD) > Stage II or eGFR <60 mL/min
- Autoimmune disease, including:
- Rheumatoid Arthritis (RA)
- Systemic Lupus Erythematosus (SLE)
- Any disorders of glucocorticoid excess or diseases requiring systemic steroids or immune-modulating therapies
- Cardiac disease deemed significant:
- Poorly controlled hypertension (BP >/=140/90)
- NYHA class III or IV congestive heart failure
- History of a significant ventricular arrhythmia
- Obesity class II or higher (BMI >/= 35)
- Moderate-to-uncontrolled diabetes HbA1c >/= 7%
- Osteoporosis
- A history of other severe systemic disorders, including significant CVA, TBI, seizure, encephalitis, meningitis, or psychiatric disorder that is deemed potentially harmful to the participant by the PI
- Positive for HIV, HBV, HCV, or syphilis
- Any of the following lab abnormalities:
- Hematology: Hgb < 10 g/dl, ANC < 1.550/L, platelets < 100,000 /L >Chemistry: albumin < 3.0 g/dL, serum creatine > 1.5 x ULN, total bilirubin > 1.5 x ULN, AST/ALT/ALP > 2.0 x ULN
- Female or another gender with childbearing potential not willing to adopt barrier method(s) of contraception, plus one other form, including:
- Intrauterine system (IUS)
- Intrauterine device (IUD)
- Oral, injected, or implanted hormonal contraception
- Female or another gender who is lactating/breastfeeding or has a positive urine or serum pregnancy test at intake screening
- Any disorder that compromises the participant's ability to give appropriate informed consent or hinders the ability to perform the assessment and receive the study's interventions
- Any other condition not listed above that is deemed potentially harmful to the participant by the PI
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Standard Optimization of Autologous Stem Cells by Intranasal and Intravenous Administration to Treat Parkinson's Disease and Atypical Parkinsonism
The purpose of this study is to measure outcomes using intranasal and intravenous autologous bone marrow mesenchymal stem cells (BM-MSCs) for Parkinson Disease (PD) and Parkinson's Plus (PPS) patients.
Read the detailed description
Parkinson Disease (PD) and Parkinson-Plus Syndrome (PPS) are complex neurodegenerative diseases (NDDs) affecting more than 10 million people worldwide. The clinical application of stem cell therapy holds great promise in the treatment of NDDs by promoting regeneration and modulating immune responses with bone marrow aspirate, in particular, holding considerable potential in neural repair and recovery. However, current approaches often rely on university-based laboratories and invasive delivery approaches, raising patient safety, accessibility, and cost concerns. Additionally, NDDs present with distributive and heterogenous pathology, complicating treatment strategies. As pharmaceutical and biotech companies develop targeted stem cell therapies, most focus on localized brain structures rather than targeting PD/PPS systemically. Advancing consensus between scientific research and clinical application is critical for earlier detection in the prodromal phase, identifying epigenetic risk factors, and developing therapeutics that provide a broader, more effective treatment.
The primary objective of this study is to measure outcomes using autologus bone marrow mesenchymal stem cells (BM-MSCs) on motor and non-motor function in persons with PD/PPS. The trial will include 60 participants (40 with PD, 20 with PPS) who will complete 7 scheduled encounters (4 in-person visits, 3 remote visits) that occur every 3 months in an alternating manner. There will be 4 treatment groups (2 PD, 2 PPS) who will be administered intranasal bone marrow aspirate and intravenous bone marrow aspirate in a crossover pattern at three of the four in-person visits (Day 0, 6 months and 12 months).
- Conditions
- Atypical Parkinsonism, Parkinson Disease (PD)
- Being tested
- Autologous mesenchymal stem cells
- Keywords
- Atypical Parkinsonism, Parkinson-Plus Syndrome, Stem Cells, MSCs, Epigenetics, Metagenomics, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous mesenchymal stem cellsBiological
- Participant's blood is drawn at the start of each visit.
- Bone marrow aspirate is drawn from the posterior aspect of the pelvis and is subsequently harvested and processed.
- The following procedures are administered in a crossover design (Day 0 and 6 months):
- Intranasal bone marrow aspirate administration (INA BMAC) OR Sham INA
- Intravenous bone marrow aspirate administration (IV BMA) OR Sham IVA
- At 12 months, all participants receive IV BMA + INA BMAC
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease Group 1 | Experimental | Day 0 - Sham IV + INA BMAC 6 months - IV BMA + Sham INA 12 months - IV BMA + INA BMAC Receives: Biological: Autologous mesenchymal stem cells |
| Parkinson Plus Syndrome Group 1 | Experimental | Day 0 - Sham IV + INA BMAC 6 months - IV BMA + Sham INA 12 months - IV BMA + INA BMAC Receives: Biological: Autologous mesenchymal stem cells |
| Parkinson Disease Group 2 | Experimental | Day 0 - IV BMA + Sham INA 6 months - Sham IV + INA BMAC 12 months - IV BMA + INA BMAC Receives: Biological: Autologous mesenchymal stem cells |
| Parkinson Plus Syndrome Group 2 | Experimental | Day 0 - IV BMA + Sham INA 6 months - Sham IV + INA BMAC 12 months - IV BMA + INA BMAC Receives: Biological: Autologous mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement-Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)-III
The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination (33 scores summed from 18 questions) conducted by the rater. Total scores can range from 0 to 141, with higher scores indicating worse disease severity.
Measured: Day 0, 6, 12 and 18 months
10-meter Walk Test (10MWT)
The 10MWT is an assessment of gait speed over a short distance (2 meters ramp up, 6 meters walking, 2 meters ramp down). The aforementioned distances will be pre-measured for accuracy and only the middle 6 meters will be timed. Participants will be asked to walk at a comfortable pace for 2 trials and a fast pace for 2 trials.
Measured: Day 0, 6, 12 and 18 months
Five Times Sit to Stand (FTSTS)
The FTSTS objectively assesses the time it takes to complete 5 sit-to-stands and is a method to observe movement strategies or compensations. The test will be performed in a standard chair with participants instructed to stand up and sit down 5 times as quickly as possible.
Measured: Day 0, 6, 12 and 18 months
Mini Balance Evaluation Systems Test (Mini-BESTest)
The Mini-BESTest aims to target 6 different balance control systems. The measure includes 14 items assessing anticipatory postural adjustments, reactive balance control, sensory orientation, and dynamic gait. This is scored on a 3-item ordinal scale resulting in a maximum score of 28.
Measured: Day 0, 6, 12 and 18 months
The Short Parkinson's Evaluation Scale (SPES)/Scales for Outcomes in Parkinson's Disease - Motor Function (SPES/SCOPA - Motor)
The SPES/Scales for Outcomes in Parkinson's will be used to evaluate motor function and includes 3 sections: Motor evaluation (10 items, maximum of 42 points), Activities of Daily Living (7 items, maximum 21 points), and Motor complications (4 items, maximum 12 points - with 2 items on motor fluctuation [6 points] and 2 on dyskinesias [6 points]). Response options for all items range 0 to 3.
Measured: Day 0, 6, 12 and 18 months
Modified Hoehn & Yahr Scale
The Modified Hoehn and Yahr Scale contains additional criteria to rate Parkinson disease symptoms on a scale of 1-5. Higher scores indicate increased disease progression.
Measured: Day 0, 6, 12 and 18 months
Montreal Cognitive Assessment (MoCA)
The MoCA is a rapid screen of cognitive abilities to detect mild cognitive dysfunction. Participants are tested on 16 items that cover multiple cognitive domains. The score ranges from 0-30, with higher scores indicating less cognitive impairment.
Measured: Day 0, 3, 6, 9, 12, 15 and 18 months
Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS)
The PSP-CDS was developed to assess clinical deficits in patients with Progressive Supranuclear Palsy (PSP). The scale measures severity of deficits in seven patient-related clinical domains: Akinesia-rigidity, Bradyphrenia, Communication, Dysphagia, Eye movements, Finger dexterity, and Gait \& balance; each scored from 0 to 3. The sum of the individual domains provides a total score ranging from 0 (no deficit in any domain) to 21 (severe deficit in all domains) with higher scores representing a worse outcome.
Measured: Day 0, 6, 12 and 18 months
Unified Multiple System Atrophy Rating Scale (UMSARS)
The UMSARS will be used as a clinical rating scale to provide measures of disease progression in multiple systems atrophy. It is composed of four subscales: UMSARS-I (historical review of disease-related impairments, 12 items, scored 0 to 4), UMSARS-II (motor examination, 14 items, scored 0 to 4), UMSARS-III (autonomic examination - records blood pressure and heart rate in the supine and standing positions), and UMSARS-IV (global disability scale - rates chore-based disability, 1 item, ranges from 1 to 5). Higher scores on the UMSARS indicate greater disability.
Measured: Day 0, 6, 12 and 18 months
Cortical Basal Ganglia Functional Scale (CBFS)
The CBFS is a rating scale that evaluates experiences in daily living (EDLs), behavioral, language, and cognitive impairments in patients with 4 repeat tauopathies (4RTs). The CBFS consists of 14 questions on Motor EDLs and 17 questions on Non-motor EDLs, each of which are rated on a Likert scale rating function from 0 to 4, where 0 = Normal or No problems and 4 = Severe problems. The questions are for the patient, but should be answered by both the patient and their caregiver together.
Measured: Day 0, 6, 12 and 18 months
Parkinson's Disease Questionnaire - 39 (PDQ-39)
The PDQ-39 is a self report questionnaire that assesses quality of life over the past month across 8 different dimensions (Activities of daily living, Attention and working memory, Cognition, Communication, Depression, Functional mobility, Quality of life, Social relationships, Social relationships, Social support). Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life. Each dimension total score ranges from 0 (never having difficulty) to 100 (always having difficulty) with lower scores being a better outcome.
Measured: Day 0, 3, 6, 9, 12, 15 and 18 months
The Scales for Outcomes in Parkinson's disease - Cognition (SCOPA-COG)
The SCOPA-COG consists of 10 items divided over four domains: memory (4 items), attention (2 items), executive function (3 items), and visuospatial function (1 item). Scores range from 0-43, with higher scores reflecting better performance.
Measured: Day 0, 3, 6, 9, 12, 15 and 18 months
The Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction
The SCOPA-AUT is self-completed by patients and consists of 23 items assessing the following domains: Gastrointestinal (7 items), Urinary (6 items), Cardiovascular (3 items), Thermoregulatory (4 items), Pupillomotor (1 item), and Sexual (2 items female, 2 items male). The maximum score is 69, with the score for each item ranging from 0 (never experiencing the symptom) to 3 (often experiencing the symptom).
Measured: Day 0, 3, 6, 9, 12, 15 and 18 months
Non-Motor Symptoms Questionnaire (NMSQ)
The NMSQ is a comprehensive assessment of a diverse range of non-motor symptoms which can occur in all stages of Parkinson's disease. It is a patient-based screening tool designed to draw attention to the presence of non-motor symptoms in patients. Responses are marked as "yes" or "no" in regard to symptoms over the past month.
Measured: Day 0, 3, 6, 9, 12, 15 and 18 months
MDS Non-Motor Rating Scale (MDS-NMS)
The MDS-NMS is a rater completed assessment that measures frequency and severity of 13 non-motor domains, over 52 items and covers a range of key non-motor symptoms both PD and treatment related. Scores are rated based on symptoms over the past month on frequency (scale from 0 to 4) and severity (scale 0 to 4), with higher scores reflecting more frequent and severe symptoms.
Measured: Day 0, 3, 6, 9, 12, 15 and 18 months
Secondary outcomes (3)
Resting state brain activation pattern (fMRI analysis)
An anatomical scan using fMRI at the University of Colorado Intermountain Neuroimaging Consortium will performed during a resting state to determine changes in atrophy pattern, volume, cortical thickness, ventricle enlargement, white matter hyperintensities, and magnetic inhomogeneity effects
Measured: Day 0 and 18 months
Active brain activation pattern (fMRI analysis)
A motor sequencing tapping task and higher order cognitive task (Stroop test) at the University of Colorado Intermountain Neuroimaging Consortium will be performed during the fMRI to determine changes in atrophy pattern, volume, cortical thickness, ventricle enlargement, white matter hyperintensities, and magnetic inhomogeneity effects.
Measured: Day 0 and 18 months
Active performance accuracy and rate (fMRI analysis)
A motor sequencing tapping task and higher order cognitive task (Stroop test) at the University of Colorado Intermountain Neuroimaging Consortium will be performed during the fMRI to determine changes accuracy and rate of responding for motor performance and cognitive performance.
Measured: Day 0 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical ParkinsonismStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apeiron Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Boulder
- Responsible party
- Principal investigator, Jason Glowney, Apeiron Research Center
- Investigators
- Jason Glowney, MD, MSc, Principal investigator, Apeiron Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858254
- Sponsor's protocol ID
- ARC-PD-PPS-01
- Acronym
- SO-ASC-INIVAT
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Optimization of Autologous Stem Cells by Intranasal and Intravenous Administration to Treat Parkinson's Disease and Atypical Parkinsonism
- ClinicalTrials.gov ID
- NCT06858254
- Acronym / sponsor ID
- SO-ASC-INIVAT / ARC-PD-PPS-01
- Conditions
- Atypical Parkinsonism, Parkinson Disease (PD)
- Keywords
- Atypical Parkinsonism, Parkinson-Plus Syndrome, Stem Cells, MSCs, Epigenetics, Metagenomics, Parkinson's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Apeiron Research CenterUniversity, hospital or other
- Collaborators
- University of Colorado, Boulder
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
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 measure outcomes using intranasal and intravenous autologous bone marrow mesenchymal stem cells (BM-MSCs) for Parkinson Disease (PD) and Parkinson's Plus (PPS) patients.
Detailed description
Parkinson Disease (PD) and Parkinson-Plus Syndrome (PPS) are complex neurodegenerative diseases (NDDs) affecting more than 10 million people worldwide. The clinical application of stem cell therapy holds great promise in the treatment of NDDs by promoting regeneration and modulating immune responses with bone marrow aspirate, in particular, holding considerable potential in neural repair and recovery. However, current approaches often rely on university-based laboratories and invasive delivery approaches, raising patient safety, accessibility, and cost concerns. Additionally, NDDs present with distributive and heterogenous pathology, complicating treatment strategies. As pharmaceutical and biotech companies develop targeted stem cell therapies, most focus on localized brain structures rather than targeting PD/PPS systemically. Advancing consensus between scientific research and clinical application is critical for earlier detection in the prodromal phase, identifying epigenetic risk factors, and developing therapeutics that provide a broader, more effective treatment.
The primary objective of this study is to measure outcomes using autologus bone marrow mesenchymal stem cells (BM-MSCs) on motor and non-motor function in persons with PD/PPS. The trial will include 60 participants (40 with PD, 20 with PPS) who will complete 7 scheduled encounters (4 in-person visits, 3 remote visits) that occur every 3 months in an alternating manner. There will be 4 treatment groups (2 PD, 2 PPS) who will be administered intranasal bone marrow aspirate and intravenous bone marrow aspirate in a crossover pattern at three of the four in-person visits (Day 0, 6 months and 12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease Group 1 | Experimental | Biological: Autologous mesenchymal stem cellsDay 0 - Sham IV + INA BMAC 6 months - IV BMA + Sham INA 12 months - IV BMA + INA BMAC |
| Parkinson Plus Syndrome Group 1 | Experimental | Biological: Autologous mesenchymal stem cellsDay 0 - Sham IV + INA BMAC 6 months - IV BMA + Sham INA 12 months - IV BMA + INA BMAC |
| Parkinson Disease Group 2 | Experimental | Biological: Autologous mesenchymal stem cellsDay 0 - IV BMA + Sham INA 6 months - Sham IV + INA BMAC 12 months - IV BMA + INA BMAC |
| Parkinson Plus Syndrome Group 2 | Experimental | Biological: Autologous mesenchymal stem cellsDay 0 - IV BMA + Sham INA 6 months - Sham IV + INA BMAC 12 months - IV BMA + INA BMAC |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (34 listed)
- Other non-PD/PPS Parkinsonism (e.g., drug-induced, vascular parkinsonism)
- No strong familial history of PD/PPS not attributable to environmental exposure or any known genetic predisposition to PD/PPS
- Unable to receive/tolerate neuroimaging (e.g., MRI-incompatible cardiac pacemaker)
- Unable to maintain/tolerate supine position with cervical neck extension
- Active systemic infection or local infection near the lumbar pelvis region
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 |
|---|---|---|
| Autologous mesenchymal stem cells1. Participant's blood is drawn at the start of each visit. 2. Bone marrow aspirate is drawn from the posterior aspect of the pelvis and is subsequently harvested and processed. 3. The following procedures are administered in a crossover design (Day 0 and 6 months): * Intranasal bone marrow aspirate administration (INA BMAC) OR Sham INA * Intravenous bone marrow aspirate administration (IV BMA) OR Sham IVA 4. At 12 months, all participants receive IV BMA + INA BMAC | Biological | Parkinson Disease Group 1, Parkinson Disease Group 2, Parkinson Plus Syndrome Group 1, Parkinson Plus Syndrome Group 2 |
Primary outcome
Movement-Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)-III
Time frame: Day 0, 6, 12 and 18 months
The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination (33 scores summed from 18 questions) conducted by the rater. Total scores can range from 0 to 141, with higher scores indicating worse disease severity.
10-meter Walk Test (10MWT)
Time frame: Day 0, 6, 12 and 18 months
The 10MWT is an assessment of gait speed over a short distance (2 meters ramp up, 6 meters walking, 2 meters ramp down). The aforementioned distances will be pre-measured for accuracy and only the middle 6 meters will be timed. Participants will be asked to walk at a comfortable pace for 2 trials and a fast pace for 2 trials.
Five Times Sit to Stand (FTSTS)
Time frame: Day 0, 6, 12 and 18 months
The FTSTS objectively assesses the time it takes to complete 5 sit-to-stands and is a method to observe movement strategies or compensations. The test will be performed in a standard chair with participants instructed to stand up and sit down 5 times as quickly as possible.
Mini Balance Evaluation Systems Test (Mini-BESTest)
Time frame: Day 0, 6, 12 and 18 months
The Mini-BESTest aims to target 6 different balance control systems. The measure includes 14 items assessing anticipatory postural adjustments, reactive balance control, sensory orientation, and dynamic gait. This is scored on a 3-item ordinal scale resulting in a maximum score of 28.
The Short Parkinson's Evaluation Scale (SPES)/Scales for Outcomes in Parkinson's Disease - Motor Function (SPES/SCOPA - Motor)
Time frame: Day 0, 6, 12 and 18 months
The SPES/Scales for Outcomes in Parkinson's will be used to evaluate motor function and includes 3 sections: Motor evaluation (10 items, maximum of 42 points), Activities of Daily Living (7 items, maximum 21 points), and Motor complications (4 items, maximum 12 points - with 2 items on motor fluctuation [6 points] and 2 on dyskinesias [6 points]). Response options for all items range 0 to 3.
Modified Hoehn & Yahr Scale
Time frame: Day 0, 6, 12 and 18 months
The Modified Hoehn and Yahr Scale contains additional criteria to rate Parkinson disease symptoms on a scale of 1-5. Higher scores indicate increased disease progression.
Montreal Cognitive Assessment (MoCA)
Time frame: Day 0, 3, 6, 9, 12, 15 and 18 months
The MoCA is a rapid screen of cognitive abilities to detect mild cognitive dysfunction. Participants are tested on 16 items that cover multiple cognitive domains. The score ranges from 0-30, with higher scores indicating less cognitive impairment.
Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS)
Time frame: Day 0, 6, 12 and 18 months
The PSP-CDS was developed to assess clinical deficits in patients with Progressive Supranuclear Palsy (PSP). The scale measures severity of deficits in seven patient-related clinical domains: Akinesia-rigidity, Bradyphrenia, Communication, Dysphagia, Eye movements, Finger dexterity, and Gait \& balance; each scored from 0 to 3. The sum of the individual domains provides a total score ranging from 0 (no deficit in any domain) to 21 (severe deficit in all domains) with higher scores representing a worse outcome.
Unified Multiple System Atrophy Rating Scale (UMSARS)
Time frame: Day 0, 6, 12 and 18 months
The UMSARS will be used as a clinical rating scale to provide measures of disease progression in multiple systems atrophy. It is composed of four subscales: UMSARS-I (historical review of disease-related impairments, 12 items, scored 0 to 4), UMSARS-II (motor examination, 14 items, scored 0 to 4), UMSARS-III (autonomic examination - records blood pressure and heart rate in the supine and standing positions), and UMSARS-IV (global disability scale - rates chore-based disability, 1 item, ranges from 1 to 5). Higher scores on the UMSARS indicate greater disability.
Cortical Basal Ganglia Functional Scale (CBFS)
Time frame: Day 0, 6, 12 and 18 months
The CBFS is a rating scale that evaluates experiences in daily living (EDLs), behavioral, language, and cognitive impairments in patients with 4 repeat tauopathies (4RTs). The CBFS consists of 14 questions on Motor EDLs and 17 questions on Non-motor EDLs, each of which are rated on a Likert scale rating function from 0 to 4, where 0 = Normal or No problems and 4 = Severe problems. The questions are for the patient, but should be answered by both the patient and their caregiver together.
Parkinson's Disease Questionnaire - 39 (PDQ-39)
Time frame: Day 0, 3, 6, 9, 12, 15 and 18 months
The PDQ-39 is a self report questionnaire that assesses quality of life over the past month across 8 different dimensions (Activities of daily living, Attention and working memory, Cognition, Communication, Depression, Functional mobility, Quality of life, Social relationships, Social relationships, Social support). Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life. Each dimension total score ranges from 0 (never having difficulty) to 100 (always having difficulty) with lower scores being a better outcome.
The Scales for Outcomes in Parkinson's disease - Cognition (SCOPA-COG)
Time frame: Day 0, 3, 6, 9, 12, 15 and 18 months
The SCOPA-COG consists of 10 items divided over four domains: memory (4 items), attention (2 items), executive function (3 items), and visuospatial function (1 item). Scores range from 0-43, with higher scores reflecting better performance.
The Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction
Time frame: Day 0, 3, 6, 9, 12, 15 and 18 months
The SCOPA-AUT is self-completed by patients and consists of 23 items assessing the following domains: Gastrointestinal (7 items), Urinary (6 items), Cardiovascular (3 items), Thermoregulatory (4 items), Pupillomotor (1 item), and Sexual (2 items female, 2 items male). The maximum score is 69, with the score for each item ranging from 0 (never experiencing the symptom) to 3 (often experiencing the symptom).
Non-Motor Symptoms Questionnaire (NMSQ)
Time frame: Day 0, 3, 6, 9, 12, 15 and 18 months
The NMSQ is a comprehensive assessment of a diverse range of non-motor symptoms which can occur in all stages of Parkinson's disease. It is a patient-based screening tool designed to draw attention to the presence of non-motor symptoms in patients. Responses are marked as "yes" or "no" in regard to symptoms over the past month.
MDS Non-Motor Rating Scale (MDS-NMS)
Time frame: Day 0, 3, 6, 9, 12, 15 and 18 months
The MDS-NMS is a rater completed assessment that measures frequency and severity of 13 non-motor domains, over 52 items and covers a range of key non-motor symptoms both PD and treatment related. Scores are rated based on symptoms over the past month on frequency (scale from 0 to 4) and severity (scale 0 to 4), with higher scores reflecting more frequent and severe symptoms.
3 secondary outcomes
Resting state brain activation pattern (fMRI analysis)
Time frame: Day 0 and 18 months
Active brain activation pattern (fMRI analysis)
Time frame: Day 0 and 18 months
Active performance accuracy and rate (fMRI analysis)
Time frame: Day 0 and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- 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.
Jason Glowney, MD, MSc principal investigator
Apeiron Research Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous mesenchymal stem cells in people with Atypical Parkinsonism and Parkinson Disease (PD), run by Apeiron Research Center.
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 0 inclusion and 34 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: opening soon, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenna Zajac, PT, DPT, PhD (720-593-7595, jzajac@apeironresearch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement-Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)-III (time frame: Day 0, 6, 12 and 18 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.