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Treating Parkinson's Disease with Autologous Stem Cell-Derived Dopaminergic Neurons

This study is testing a new treatment for Parkinson's disease called autologous dopaminergic cell implantation. This involves taking your own skin cells and turning them into special brain cells (dopaminergic progenitor cells) that are then injected into your brain. Researchers want to see if this treatment is safe and tolerable. They will be looking at your health and how you feel for two years after the procedure. You might be able to join if you are 45 to 80 years old, have had Parkinson's disease for at least five years, and meet specific criteria for your Parkinson's symptoms. This study plans to enroll 8 participants, but its current status is unclear.

Study design
This is a Phase I study, meaning it's an early-stage trial focused on safety. It is open-label, so both you and the study team will know what treatment you receive. Eight participants are planned.
What's involved
You would have dopaminergic progenitor cells, made from your own skin, injected into your brain. Your safety and how well you tolerate the procedure will be assessed through clinical evaluations and brain scans (CT, MRI, and 18F-DOPA PET).
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability will be measured for two years after the cell implantation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06687837

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

Recruiting
PHASE1Ages 45–80InterventionalTreatment
Jeffrey S. Schweitzer, MD, PhD
~8 participants
Updated 2026-03-25 on ClinicalTrials.gov
What's tested:autologous dopaminergic cell implantation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability
Measured over 2 years from time of implantation

Conditions

Parkinson Disease

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Parkinson Disease

NCT06687837

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Jeffrey S Schweitzer, MD, PhD
[email protected]
6177261799
Email the study team

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Eligibility criteria

Inclusion

Diagnosis of Parkinson's Disease consistent with the Movement Disorders Society 2015 Parkinson's diagnostic criteria.
Age 45 - 80 years
English proficiency sufficient to understand the consent form and participate in a discussion of risks and benefits
At least 5 years since Parkinson's disease motor symptom onset
Modified Hoehn and Yahr stage 3-4 in "off"-medication state
Motor symptoms responsive to levodopa and/or dopamine agonist, defined as taking at least 300 mg/day of levodopa and exhibiting improvement between "off" and "on" MDS-UPDRS of at least 30%
At least 3 hours of cumulative "off" time per day
Stable regimen of Parkinson's medications, including levodopa and dopamine agonists, for at least 4 weeks prior to screening.
Acceptable surgical laboratory values including:
Subject agrees to defer elective neurological surgery, including deep brain stimulation or lesional procedure for PD, invasive treatments, including levodopa or apomorphine infusion, or pump- pump-administered levodopa intestinal gel, until after the study's primary outcome is completed.
Findings on baseline 18F-DOPA PET imaging consistent with dopaminergic denervation of the putamen
Subject is willing and able to comply with all study visits and procedures in the opinion of the Investigator.

Exclusion

Subjects unable to give consent due to dementia or psychosis.
Montreal Cognitive Assessment (MoCA) score \< 26
Subjects with a first-degree relative with Parkinson's disease or with a known genetic mutation predisposing to the development of Parkinson's disease (i.e. this initial study is confined to the more common "sporadic" vs a "genetic" form of the disease).
Atypical Parkinsonism (Parkinson's-Plus syndrome, secondary parkinsonism)
Moderate or severe levodopa-induced dyskinesias in any body segment (such patients were found to be more prone to graft-induced dyskinesias in the fetal tissue studies that are proof of priniciple for this therapy)
Neurologic history or imaging demonstrating brain pathology not directly related to Parkinson's disease that is likely to interfere with study compliance or assessment of Parkinson's related motor disability.
History of stroke or transient ischemic attack
History of subarachnoid hemorrhage
Presence or history of psychosis within 12 months of screening
Suicidal ideation associated with intent or plan in the past 12 months (an answer of "yes" to C-SSRS questions 4 or 5) or with a previous history of suicide attempts in the past 5 years.
History of intracranial surgery including deep brain stimulation, focused ultrasound, stereotactic or radiosurgical lesion therapy
History of malignancy within 5 years. Exceptions will be made for treated cutaneous squamous cell or basal cell carcinoma without evidence of metastasis.
Use of anticoagulation / antiplatelet agents that cannot be stopped for one week in advance of and two days following surgery without significant risk to the subject
Use of chronic immunosuppressive therapy including chronic steroids
Contraindication to MRI or MRI contrast agents
Pregnant or nursing women
Subjects with active cardiovascular and cerebrovascular disease within 6 months prior to signing the informed consent form.
History of severe heart failure (congestive heart failure of New York Heart Association Class II or above or left ventricular ejection fraction \< 35% by any examination method), unstable angina pectoris and myocardial infarction/
Severe arrhythmia
History of cardiovascular surgery (cardiac, vascular stent surgery, angioplasty)
Patients with major vascular diseases (aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis)
Hypertensive patients with poorly controlled blood pressure (defined as blood pressure consistently above 160/100 mmHg despite treatment with antihypertensive drugs) and patients with severe postural hypotension
Diabetic patients with poorly controlled blood glucose (glycosylated hemoglobin \> 9.0%, or fasting plasma glucose (FPG) ≥ 11.1 mmol/L);
Subjects with alcohol or drug addiction

What this trial measures

  • Safety and Tolerability2 years from time of implantation

    Incidence and severity of adverse events and serious adverse events