Improve walking and reduce stiffness
- Trial ID
- NCT07572071
- Official Title
- Evaluation of the Safety and Feasibility of a Single Transplantation of 10 Million Human Embryonic Stem Cell-Derived Dopaminergic Progenitor Cells Into the Bilateral Striatum of Patients With Moderately Severe Parkinson's Disease: a Multicenter, Open-label, Single-arm Phase I Clinical Trial
- Goal
- Improve walking and reduce stiffness
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Royan Institute
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson Disease (PD)
- Interventions
- Dopacell, Immunosuppressive Regimen, Customized microinjection device
Summary For Families
Aiming to restore dopamine signaling in the striatum to improve motor function and test safety and feasibility in moderately severe Parkinson's, the trial evaluates a single transplant of embryonic stem cell-derived dopaminergic progenitors. The team will inject 10 million progenitor cells into both sides of the striatum with a customized microinjection device; the cells are intended to mature into dopamine-producing neurons that release dopamine and may smooth movements and potentially reduce dependence on levodopa, and participants will receive an immunosuppressive regimen (tacrolimus, prednisolone, basiliximab) to prevent rejection. Ideal participants are 30 to 70 years old, have had PD for more than 5 years, show a clear clinical response to levodopa, have moderate disease (Hoehn and Yahr 2 or 3 OFF) with only minimal dyskinesia, and have no major immune problems, brain lesions, active infections, dementia, prior DBS or other conflicting treatments. This is an open-label Phase 1 feasibility study enrolling about 10 people.
Locations
- Royan Institute, Tehran, Iran
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Dopacell. Aiming to restore dopamine signaling in the striatum to improve motor function and test safety and feasibility in moderately severe Parkinson's, the trial evaluates a single transplant of embryonic stem cell-derived dopaminergic progenitors. The team will inject 10 million progenitor cells into both sides of the striatum with a customized microinjection device; the cells are intended to mature into dopamine-producing neurons that release dopamine and may smooth movements and potentially reduce dependence on levodopa, and participants will receive an immunosuppressive regimen (tacrolimus, prednisolone, basiliximab) to prevent rejection. Ideal participants are 30 to 70 years old, have had PD for more than 5 years, show a clear clinical response to levodopa, have moderate disease (Hoehn and Yahr 2 or 3 OFF) with only minimal dyskinesia, and have no major immune problems, brain lesions, active infections, dementia, prior DBS or other conflicting treatments. This is an open-label Phase 1 feasibility study enrolling about 10 people.
- Who can participate?
- Participants must be between 30 Years and 70 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 3 years.
- 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.