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
Plain-Language Summary
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.