Actively Recruiting

Phase 1
Age: 45Years - 80Years
All Genders
NCT06687837

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

Led by Jeffrey S. Schweitzer, MD, PhD · Updated on 2026-03-25

8

Participants Needed

1

Research Sites

187 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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, invasive treatments, or 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.
Not Eligible

You will not qualify if you...

  • Unable to give consent due to dementia or psychosis.
  • Montreal Cognitive Assessment (MoCA) score < 26
  • First-degree relative with Parkinson's disease or known genetic mutation predisposing to Parkinson's disease.
  • Atypical Parkinsonism (Parkinson's-Plus syndrome, secondary parkinsonism)
  • Moderate or severe levodopa-induced dyskinesias in any body segment
  • Neurologic history or brain pathology likely to interfere with study compliance or motor disability assessment.
  • History of stroke, transient ischemic attack, or subarachnoid hemorrhage
  • Psychosis within 12 months of screening
  • Suicidal ideation with intent or plan in the past 12 months or suicide attempts in the past 5 years
  • History of intracranial surgery including deep brain stimulation or lesion therapy
  • History of malignancy within 5 years except treated cutaneous squamous or basal cell carcinoma without metastasis
  • Use of anticoagulation/antiplatelet agents that cannot be stopped safely around surgery
  • Use of chronic immunosuppressive therapy including steroids
  • Contraindication to MRI or MRI contrast agents
  • Pregnant or nursing women
  • Active cardiovascular and cerebrovascular disease within 6 months prior to consent
  • History of severe heart failure, unstable angina, myocardial infarction, severe arrhythmia, or cardiovascular surgery
  • Major vascular diseases such as aortic aneurysm or carotid artery stenosis
  • Poorly controlled hypertension or severe postural hypotension
  • Poorly controlled diabetes (HbA1c > 9.0%, or fasting plasma glucose ≥ 11.1 mmol/L)
  • Alcohol or drug addiction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

J

Jeffrey S Schweitzer, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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