Parkinson's patients get brain transplants of their own cells
NCT ID NCT06422208
First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 3 times
Summary
This early-stage trial tests whether transplanting dopamine neurons made from a patient's own stem cells into the brain is safe for Parkinson's disease. Six people aged 55 to 80 with Parkinson's for at least 5 years will receive the cells in a single surgery. The main goal is to check for side effects, but researchers will also monitor motor function changes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous iPSC-derived dopamine neurons
- What this could lead to
- If successful, this could point toward a new way to replace lost brain cells and improve motor function in Parkinson's disease.
- What could go wrong
- This is a very early, small safety trial with only 6 people. The procedure involves brain surgery, which carries risks like infection or bleeding. It may not improve symptoms.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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55 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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: * Males and females between ages 55 to eighty. * Diagnosis of Parkinson's disease with motor symptoms by neurologist according to Movement Disorder Society (MDS) 2015 Clinical Diagnostic Criteria for Parkinson's disease. * Diagnosis of Parkinson's disease for at least 5 years. * Dopamine drug responsiveness demonstrated by a positive "on/off" test with at least a 30% improvement on UPDRS III (motor) scale. * No gross abnormalities on MRI, including hydrocephalus or extensive white matter disease. * No significant cognitive impairment (Montreal Cognitive Assessment). * No significant untreated depression (Beck Depression Inventory 2). * Up to date cancer screening per primary MD. * Able to understand trial requirements and intervention procedures and provide written informed consent. Exclusion Criteria: * History of intracranial surgeries. * Any previous thalamotomy, pallidotomy or deep brain stimulation. * Atypical Parkinsonism (Parkinsonism-Plus syndrome, secondary parkinsonism, hereditary parkinsonism) * History of psychiatric disorders including schizophrenia or psychosis likely to compromise with ability to comply with trial protocol requirements. * Prior history of intracerebral, subdural, or epidural hemorrhage. * History of malignancy within 5 years. * Inability to have an MRI. * Life expectancy \< 6 months due to concomitant illnesses. * Ingestion of investigational drug or recipient of investigational procedure within 6 months prior to trial. * Subjects with active cardiovascular and cerebrovascular disease within 6 months prior to signing the informed consent form: 1. 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 2. Severe arrhythmia 3. History of cardiovascular surgery (cardiac, vascular stent surgery, angioplasty); 4. History of stroke or transient ischemic attack 5. History of subarachnoid hemorrhage 6. Subjects with major vascular diseases (aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis) * Hypertensive subjects with poorly controlled blood pressure (defined as blood pressure above 160/100 mmHg despite treatment with antihypertensive drugs) and subjects with severe postural hypotension. * Abnormal pre-operative coagulation labs. * Any necessary chronic anticoagulation medication in use (not including antiplatelet therapy and chronic NSAID). * Diabetic subjects with poorly controlled blood glucose (glycosylated hemoglobin \> 9.0%, or fasting plasma glucose (FPG) ≥ 11.1 mmol/L). * Active infectious disease. Subjects known to have tested positive for HIV, Human T-lymphotropic Virus, Hepatitis B Virus, Hepatitis C Virus, Cytomegalovirus (IgM \> IgG) and/or syphilis will be evaluated by an expert as to subject eligibility based on the subject's infectious status. * Any illness which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromise subject safety, or interfere with the interpretation of the trial results. * Active clinical infection being treated by antibiotics within one week of enrollment. * Known drug or alcohol dependence or any other clinical factors or conditions (for example, history of seizures) which will interfere with the trial conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. * Unwilling and/or not able to give written informed consent.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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
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Brigham & Women's Hospital
Boston, Massachusetts, 02215, United States
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