Recruiting · registry statusTesting a person’s own cells as a brain treatment
Researchers check the safety and tolerability of transplanting nerve-cell precursors made from a person’s own cells into the brain.
Testing a treatment or activity · Study reference: NCT06687837
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.
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Looking for volunteers
- Start (reported actual date)
- 2025-04-29
- Main measurements finished (planned)
- 2027-12
- Study finished (planned)
- 2028-12
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
Jeon J, Cha Y, Hong YJ, Lee IH, Jang H, Ko S, Naumenko S, Kim M, Ryu HL, Shrestha Z, Lee N, Park TY, Park H, Kim SH, Yoon KJ, Song B, Schweitzer J, Herrington TM, Kong SW, Carter B, Leblanc P, Kim KS. Pre-clinical safety and efficacy of human induced pluripotent stem cell-derived products for autologous cell therapy in Parkinson's disease. Cell Stem Cell. 2025 Mar 6;32(3):343-360.e7. doi: 10.1016/j.stem.2025.01.006. Epub 2025 Feb 13. ↗
Registry derived research reference
Who can join?
Ages 45 years to 80 years · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
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
Full study name & original research details
Official study title
Phase I Trial of Autologous Induced Pluripotent Stem Cell-derived Dopaminergic Progenitor Cell Transplantation for Parkinson's Disease
Short title used by the registry
Treating Parkinson's Disease Through Transplantation of Autologous Stem Cell-Derived Dopaminergic Neurons
Original description
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.
Further description from the registry
This Phase I, open-label clinical trial aims to assess the feasibility and safety of autologous midbrain dopaminergic progenitor cell (mDAP) transplantation for the treatment of Parkinson's disease. mDAPs will be produced for each participant from a fibroblast sample and then transplanted bilaterally into the putamen under general anesthesia. The study will assess the safety and tolerability of the cell transplant procedure through clinical assessments and neuroimaging (CT, MRI and 18F-DOPA PET) over a 2-year follow-up period.
Conditions reported: Parkinson Disease
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- autologous dopaminergic cell implantation
- Phases
- PHASE1
- Sponsor
- Jeffrey S. Schweitzer, MD, PhD
- Start date reported by registry
- 2025-04-29 (actual)
Registry updated: 2026-03-25 · Status last verified by the registry submitter: 2026-03
Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Jeffrey S Schweitzer, MD, PhD · 6177261799 · JSCHWEITZER1@mgh.harvard.edu
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Massachusetts General Hospital
Boston, Massachusetts, United States
RecruitingJeffrey S Schweitzer, MD, PhD · 617-726-1799 · jschweitzer1@mgh.harvard.edu
Dolores Smith · 617-726-1799 · vprathivadi@mgh.harvard.edu
Facility not reported
United States
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.