Reduce off period motor fluctuations
- Trial ID
- NCT07166757
- Official Title
- A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Human Allogeneic Induced Pluripotent Stem Cell-derived Dopaminergic Neural Progenitor Cell Injection in the Treatment of Early-onset Parkinson's Disease
- Goal
- Reduce off period motor fluctuations
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 90 participants
- Conditions
- Parkinson Disease (PD)
- Interventions
- human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection
Summary For Families
The goal is to replace or supplement the lost dopamine-producing cells in people with early-onset Parkinson's so off-periods and disabling motor fluctuations are reduced and movement becomes more stable. The treatment injects lab-grown human allogeneic iPSC-derived dopaminergic neural progenitor cells into the brain, where they can mature into dopamine-making neurons, release dopamine locally and potentially reconnect with motor circuits, which could lower reliance on levodopa and smooth motor highs and lows. They are looking for people whose Parkinson's began between ages 18 and 50, who are now 18 to 70 years old, have had the disease at least 5 years, show a clear L-dopa response but still have significant off-period motor problems despite stable medication. Candidates must be able to undergo neurosurgery and agree to long-term follow-up and restrictions like avoiding other cell therapies or elective brain procedures for 24 months.
Locations
- Huashan Hospital, Fudan University, Shanghai, Shanghai Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection. The goal is to replace or supplement the lost dopamine-producing cells in people with early-onset Parkinson's so off-periods and disabling motor fluctuations are reduced and movement becomes more stable. The treatment injects lab-grown human allogeneic iPSC-derived dopaminergic neural progenitor cells into the brain, where they can mature into dopamine-making neurons, release dopamine locally and potentially reconnect with motor circuits, which could lower reliance on levodopa and smooth motor highs and lows. They are looking for people whose Parkinson's began between ages 18 and 50, who are now 18 to 70 years old, have had the disease at least 5 years, show a clear L-dopa response but still have significant off-period motor problems despite stable medication. Candidates must be able to undergo neurosurgery and agree to long-term follow-up and restrictions like avoiding other cell therapies or elective brain procedures for 24 months.
- Who can participate?
- Participants must be between 18 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/Phase 2 trial is estimated to last approximately 2 years and 6 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.