human allogeneic induced pluripote… for Parkinson's (NCT07080775)
Restore dopamine producing brain cells
- Trial ID
- NCT07080775
- Official Title
- A Phase I Clinical Study on the Safety and Tolerability of iPSC-Derived Dopaminergic Neural Progenitor Cell Injection Via Stereotaxic Brain Transplantation for the Treatment of Primary Parkinson's Disease
- Goal
- Restore dopamine producing brain cells
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 12 participants
- Conditions
- Parkinson's Disease
- Interventions
- human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection
Summary For Families
The goal is to see if a single brain transplant of lab-grown cells meant to become dopamine-producing brain cells is safe and tolerated in people with primary Parkinson's disease. The treatment is a one-time, image-guided brain surgery to place these induced pluripotent stem cell-derived dopamine precursor cells into both sides of a movement-related brain area called the putamen, followed by short-term immune-suppressing drugs while patients keep their usual Parkinson's medicines; the study will start at a low dose and gradually increase doses in small groups to watch for side effects. The trial plans to enroll 12 to 18 people aged 50 to 75 who have had Parkinson's for at least five years, have significant daily "off time" (at least 2.5 hours), have previously shown at least a 30% improvement with levodopa, and are on stable Parkinson's treatment.
Locations
- Beijing Tiantan Hospital, Beijing, Beijing 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 see if a single brain transplant of lab-grown cells meant to become dopamine-producing brain cells is safe and tolerated in people with primary Parkinson's disease. The treatment is a one-time, image-guided brain surgery to place these induced pluripotent stem cell-derived dopamine precursor cells into both sides of a movement-related brain area called the putamen, followed by short-term immune-suppressing drugs while patients keep their usual Parkinson's medicines; the study will start at a low dose and gradually increase doses in small groups to watch for side effects. The trial plans to enroll 12 to 18 people aged 50 to 75 who have had Parkinson's for at least five years, have significant daily "off time" (at least 2.5 hours), have previously shown at least a 30% improvement with levodopa, and are on stable Parkinson's treatment.
- Who can participate?
- Participants must be between 50 Years and 75 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 trial is estimated to last approximately 9 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); Surgical procedure (invasive); Injection (minimally invasive). Confirm the full schedule with the study coordinator.