Own skin cells turned brain cells: a new hope for Parkinson's?
NCT ID NCT06687837
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests if transplanting a patient's own stem cells into the brain is safe for Parkinson's disease. Researchers take skin cells, turn them into dopamine-producing brain cells, and surgically place them in the brain. Only 8 people with moderate Parkinson's will join to check for side effects and see if movement improves.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 8 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2025
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
45 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: 1. Platelets \> 100×109/L (transfusion independent) 2. Prothrombin time / partial thromboplastin time in normal range and international normalized ratio ≤ 1.3 3. Aspartate aminotransferase and alanine aminotransferase \< 2.5x the upper limit of normal 4. Serum creatinine ≤ 1.5mg/dL 5. White blood cell count \< 12×109/L. 6. Estimated glomerular filtration rate ≥ 30 mL/min/1.73m2 * 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 Criteria: * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Parkinson disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a massive data registry crack the code of Parkinson's and related brain diseases?
- Reading the Brain's signals to predict who benefits from deep brain stimulation
- Giving Parkinson's patients a say may boost their Brain's ability to learn movement
- Brain scans probe why some Parkinson's patients freeze Mid-Step
- Can tango rewire the brain? dance program tested for Parkinson's and dementia
- Can a workout after walking practice help Parkinson's patients learn better?