Cell implant reduces off time
- Trial ID
- NCT06687837
- Official Title
- Phase I Trial of Autologous Induced Pluripotent Stem Cell-derived Dopaminergic Progenitor Cell Transplantation for Parkinson's Disease
- Goal
- Cell implant reduces off time
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Jeffrey S. Schweitzer, MD, PhD
- Study Type
- INTERVENTIONAL
- Enrollment
- 8 participants
- Conditions
- Parkinson Disease
- Interventions
- autologous dopaminergic cell implantation
Plain-Language Summary
The goal is to test whether implanting a person’s own lab-grown dopaminergic progenitor cells into the putamen is safe and feasible, with the hope these cells can replace lost dopamine-producing neurons and eventually improve motor symptoms. The team reprograms a patient’s cells into induced pluripotent stem cells, turns them into dopaminergic progenitors, and surgically implants them so they can mature and release dopamine long-term; because the grafts are autologous there is less need for chronic immunosuppression, and participants must stay on a stable levodopa regimen and defer device-based or infusion therapies until initial outcomes are assessed. They are looking for people aged 45 to 80 who have had Parkinson’s for at least five years, are Hoehn and Yahr stage 3,4 off medication, show clear levodopa responsiveness on at least 300 mg/day, and experience at least three hours of off time per day. This is a Phase 1 safety study enrolling about eight people, so the main focus is careful monitoring for surgical and graft-related risks rather than proving benefit.
Locations
- Massachusetts General Hospital, Boston, Massachusetts, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying autologous dopaminergic cell implantation. The goal is to test whether implanting a person’s own lab-grown dopaminergic progenitor cells into the putamen is safe and feasible, with the hope these cells can replace lost dopamine-producing neurons and eventually improve motor symptoms. The team reprograms a patient’s cells into induced pluripotent stem cells, turns them into dopaminergic progenitors, and surgically implants them so they can mature and release dopamine long-term; because the grafts are autologous there is less need for chronic immunosuppression, and participants must stay on a stable levodopa regimen and defer device-based or infusion therapies until initial outcomes are assessed. They are looking for people aged 45 to 80 who have had Parkinson’s for at least five years, are Hoehn and Yahr stage 3,4 off medication, show clear levodopa responsiveness on at least 300 mg/day, and experience at least three hours of off time per day. This is a Phase 1 safety study enrolling about eight people, so the main focus is careful monitoring for surgical and graft-related risks rather than proving benefit.
- Who can participate?
- Participants must be between 45 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 2 years and 7 months.