Replace lost dopamine producing neurons
- Trial ID
- NCT06167681
- Official Title
- A Phase I/II Study to Assess the Safety, Tolerability and Efficacy of NouvNeu001 Injection for Mid- to Late-stage Parkinson's Disease
- Goal
- Replace lost dopamine producing neurons
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- iRegene Therapeutics Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson Disease
- Interventions
- Human Dopaminergic Progenitor Cells
Plain-Language Summary
It aims to replace lost dopamine-producing neurons to ease the severe motor problems and disability that happen in mid- to late-stage Parkinson's. Doctors inject human dopaminergic progenitor cells into the brain so the cells can mature into dopamine neurons that make dopamine locally, potentially reducing symptoms and future dependence on levodopa while initially being used alongside existing meds. Looking for people aged 50 to 75, diagnosed 4 to 20 years ago, who are mid-to-late stage (Hoehn‑Yahr 2.5,4 when off), have a strong levodopa response and an MDS‑UPDRS‑III off score over 35, and who are medically fit for brain surgery and imaging, with common exclusions like prior DBS or cell therapy, active serious infections, uncontrolled medical or psychiatric conditions, or ongoing infusion/apomorphine treatments.
Locations
- Beijing Hospital, Beijing, Beijing Municipality, China
- Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Human Dopaminergic Progenitor Cells. It aims to replace lost dopamine-producing neurons to ease the severe motor problems and disability that happen in mid- to late-stage Parkinson's. Doctors inject human dopaminergic progenitor cells into the brain so the cells can mature into dopamine neurons that make dopamine locally, potentially reducing symptoms and future dependence on levodopa while initially being used alongside existing meds. Looking for people aged 50 to 75, diagnosed 4 to 20 years ago, who are mid-to-late stage (Hoehn‑Yahr 2.5,4 when off), have a strong levodopa response and an MDS‑UPDRS‑III off score over 35, and who are medically fit for brain surgery and imaging, with common exclusions like prior DBS or cell therapy, active serious infections, uncontrolled medical or psychiatric conditions, or ongoing infusion/apomorphine treatments.
- Who can participate?
- Participants must be between 50 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 1 year and 10 months.