human allogeneic induced pluripote… for Parkinson's (NCT07166757)
Reduce tremor and movement 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 tremor and movement 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 find out if a one-time injection of lab-grown donor cells that are early-stage dopamine-producing brain cells is safe, tolerable, and can improve symptoms in people with early-onset Parkinson's who still have significant motor problems despite medication. The plan is to test safety and the best dose first in a small group (6 to 12 people) with two dose levels, then run a larger, randomly assigned, double-blind test of about 81 people where some get the real cell injection plus a medication to suppress the immune response and others get a fake procedure plus a matching fake drug so neither they nor most study staff know who got which. Eligible people are those whose Parkinson's began between ages 18 and 50, who are now 18 to 70, have had the disease at least 5 years, show clear motor symptoms when off medication, and respond to levodopa but still cannot control motor fluctuations with stable treatment. People who have had prior brain surgery, prior cell therapy, certain advanced infusion treatments, active serious medical or immune conditions, cancer, or who are pregnant are among those who would be excluded.
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 find out if a one-time injection of lab-grown donor cells that are early-stage dopamine-producing brain cells is safe, tolerable, and can improve symptoms in people with early-onset Parkinson's who still have significant motor problems despite medication. The plan is to test safety and the best dose first in a small group (6 to 12 people) with two dose levels, then run a larger, randomly assigned, double-blind test of about 81 people where some get the real cell injection plus a medication to suppress the immune response and others get a fake procedure plus a matching fake drug so neither they nor most study staff know who got which. Eligible people are those whose Parkinson's began between ages 18 and 50, who are now 18 to 70, have had the disease at least 5 years, show clear motor symptoms when off medication, and respond to levodopa but still cannot control motor fluctuations with stable treatment. People who have had prior brain surgery, prior cell therapy, certain advanced infusion treatments, active serious medical or immune conditions, cancer, or who are pregnant are among those who would be excluded.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1/Phase 2 trial is estimated to last approximately 2 years and 6 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Injection (minimally invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.