Cell transplant reduces off time
- 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
- Cell transplant reduces off time
- 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
Plain-Language Summary
The goal is to replace lost dopamine-producing cells in people with mid-stage Parkinson's to improve motor symptoms and reduce daily off time when levodopa stops working as well. The approach is a stereotactic brain injection of human allogeneic iPSC-derived dopaminergic neural progenitor cells, which are meant to mature into dopamine-making neurons that integrate into the striatum and supply dopamine alongside existing levodopa therapy, with immunosuppression used around the transplant to reduce rejection risk. They are enrolling people aged 50 to 75 with clinically established Parkinson's for at least 5 years, moderate off-state disability (Hoehn-Yahr 3,4), at least 2.5 hours of off time per day and a clear levodopa response, while excluding those with severe dementia, unstable medical issues, prior DBS or recent cell therapy, or contraindications to brain surgery.
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 replace lost dopamine-producing cells in people with mid-stage Parkinson's to improve motor symptoms and reduce daily off time when levodopa stops working as well. The approach is a stereotactic brain injection of human allogeneic iPSC-derived dopaminergic neural progenitor cells, which are meant to mature into dopamine-making neurons that integrate into the striatum and supply dopamine alongside existing levodopa therapy, with immunosuppression used around the transplant to reduce rejection risk. They are enrolling people aged 50 to 75 with clinically established Parkinson's for at least 5 years, moderate off-state disability (Hoehn-Yahr 3,4), at least 2.5 hours of off time per day and a clear levodopa response, while excluding those with severe dementia, unstable medical issues, prior DBS or recent cell therapy, or contraindications to brain surgery.
- 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?
- 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 9 months.