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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.