Replace lost dopamine producing neurons
- Trial ID
- NCT06608355
- Official Title
- A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of NouvNeu001 Injection in the Treatment of Early-onset Parkinson's Disease
- Goal
- Replace lost dopamine producing neurons
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- iRegene Therapeutics Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 6 participants
- Conditions
- Early-onset Parkinson's Disease
- Interventions
- Human Dopaminergic Progenitor Cells
Plain-Language Summary
The goal is to see if a one-time neurosurgical transplantation of human dopaminergic progenitor cells can safely replace lost dopamine-producing cells and improve motor symptoms in people with early-onset Parkinson's, while monitoring for side effects and any early signs of benefit. The approach injects lab-grown dopaminergic precursor cells into the brain so they can mature into dopamine neurons and release dopamine, potentially smoothing movement problems and lowering dependence on levodopa; participants must show they respond to levodopa on an acute challenge. Eligible volunteers are adults 18 to 70 whose Parkinson's began at age 50 or younger, who are Hoehn-Yahr stage 2 to 4 off medication, have MDS-UPDRS-III scores over 30 off meds, and are medically fit for brain surgery. People with atypical parkinsonism, prior certain brain surgeries, active infections or serious medical or psychiatric conditions, recent stem-cell or infusion therapies, or who cannot commit to two years of contraception after treatment are excluded.
Locations
- Tongji Hospital Affiliated to Tongji Medical College Hust, Wuhan, Hubei, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Human Dopaminergic Progenitor Cells. The goal is to see if a one-time neurosurgical transplantation of human dopaminergic progenitor cells can safely replace lost dopamine-producing cells and improve motor symptoms in people with early-onset Parkinson's, while monitoring for side effects and any early signs of benefit. The approach injects lab-grown dopaminergic precursor cells into the brain so they can mature into dopamine neurons and release dopamine, potentially smoothing movement problems and lowering dependence on levodopa; participants must show they respond to levodopa on an acute challenge. Eligible volunteers are adults 18 to 70 whose Parkinson's began at age 50 or younger, who are Hoehn-Yahr stage 2 to 4 off medication, have MDS-UPDRS-III scores over 30 off meds, and are medically fit for brain surgery. People with atypical parkinsonism, prior certain brain surgeries, active infections or serious medical or psychiatric conditions, recent stem-cell or infusion therapies, or who cannot commit to two years of contraception after treatment are 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?
- 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 1 year and 7 months.