Not Yet RecruitingPhase 1/2

Standard Optimization of Stem Cells in Parkinson's Disease and Atypical Parkinsonism

60 participantsStarted 2025-04-01

Plain-language 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.

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

General Inclusion Criteria: * Participants aged 40-75 years old with a diagnosis of PD or PPS (DLB, PSP, MSA, CBD with parkinsonism) based upon clinical criteria and standardized testing * Participants time of documented PD or PPS is \</= 6 years * Participants with an anticipated survival of at least 3 years in the investigator's opinion * Participants who are willing and able to give informed consent * Participants who can comply with the study protocol over the 18-month duration * Stable medical profile for 60 days prior to the initial intake screening * Participants can ambulate at least 25m without assistance * No known history of heparin-induced thrombocytopenia PD Inclusion Criteria: * Idiopathic Parkinson's disease patients who meet the MDS's Clinical Diagnostic Criteria for Parkinson's disease * Responsive to levodopa or dopamine agonists defined by \>/= 33% improvement in "Off"/"On" symptoms by MDS-UPDRS-III * A modified Hoehn and Yahr stage of \</= 3 * Neuroimaging findings are consistent with PD and absent of atrophy or other brain pathology inconsistent with PD * "Normal" cognition as assessed by Montreal Cognitive Assessment (MoCA), with a value \>/= 26 PPS Inclusion Criteria: DLB - * High probability of cognitive capacity to give informed consent by the Montreal Cognitive Assessment (MoCA), with a value \>/= 23 * Probable DLB - DLB consortium: Two or more core clinical features are present (including features of parkinsonism for the study), or only one co…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Movement-Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)-III

Timeframe: Day 0, 6, 12 and 18 months

10-meter Walk Test (10MWT)

Timeframe: Day 0, 6, 12 and 18 months

Five Times Sit to Stand (FTSTS)

Timeframe: Day 0, 6, 12 and 18 months

Mini Balance Evaluation Systems Test (Mini-BESTest)

Timeframe: 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)

Timeframe: Day 0, 6, 12 and 18 months

Modified Hoehn & Yahr Scale

Timeframe: Day 0, 6, 12 and 18 months

Montreal Cognitive Assessment (MoCA)

Timeframe: Day 0, 3, 6, 9, 12, 15 and 18 months

Trial details

NCT IDNCT06858254

SponsorApeiron Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04

Contact for this trial

Jenna Zajac, PT, DPT, PhD

720-593-7595 jzajac@apeironresearch.org

View on ClinicalTrials.gov More Atypical Parkinsonism trials

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Movement-Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)-III

Timeframe: Day 0, 6, 12 and 18 months

10-meter Walk Test (10MWT)

Timeframe: Day 0, 6, 12 and 18 months

Five Times Sit to Stand (FTSTS)

Timeframe: Day 0, 6, 12 and 18 months

Mini Balance Evaluation Systems Test (Mini-BESTest)

Timeframe: 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)

Timeframe: Day 0, 6, 12 and 18 months

Modified Hoehn & Yahr Scale

Timeframe: Day 0, 6, 12 and 18 months

Montreal Cognitive Assessment (MoCA)

Timeframe: Day 0, 3, 6, 9, 12, 15 and 18 months