RecruitingPhase 1NCT06687837

Treating Parkinson's Disease Through Transplantation of Autologous Stem Cell-Derived Dopaminergic Neurons

Phase I Trial of Autologous Induced Pluripotent Stem Cell-derived Dopaminergic Progenitor Cell Transplantation for Parkinson's Disease


Sponsor

Jeffrey S. Schweitzer, MD, PhD

Enrollment

8 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to assess the safety and tolerability of the surgical transplantation of dopaminergic progenitor cells into the brains of participants with Parkinson's disease. The transplanted dopaminergic cells will be derived from the participant's own skin cells.


Eligibility

Min Age: 45 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether transplanting a patient's own stem cell-derived dopamine neurons (brain cells grown from their own stem cells) into the brain can restore function in people with moderately advanced Parkinson's disease. **You may be eligible if...** - You have been diagnosed with Parkinson's disease for at least 5 years - You are between 45 and 80 years old - Your motor symptoms significantly improve with levodopa medication (at least 30% improvement) - You have at least 3 hours of "off" time per day (when your medication is not working well) - You are proficient in English and understand the consent process - You have a modified Hoehn and Yahr stage of 3–4 when off medication **You may NOT be eligible if...** - You have dementia or a low cognitive test score (MoCA below 26) - You have atypical Parkinsonism (e.g., multiple system atrophy, PSP) - You have a known genetic form of Parkinson's disease or a first-degree relative with the condition - You have a history of stroke, brain hemorrhage, or prior brain surgery (including DBS) - You have psychosis or serious psychiatric illness - You have uncontrolled blood pressure or poorly controlled blood sugar - You are pregnant or nursing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALautologous dopaminergic cell implantation

Dopaminergic progenitor cells derived from autologous induced pluripotent stem cells will be injected into the brain in two cohorts of Parkinson's patients, one receiving low dose and the other high dose (4 and 8 million cells, respectively)


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06687837


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