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Own skin cells turned brain cells: a new hope for Parkinson's?

NCT ID NCT06687837

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.