Improve walking with dopaminergic cells
- Trial ID
- NCT07102342
- Official Title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Feasibility, and Preliminary Efficacy of NouvNeu001 in Patients With Advanced Parkinson's Disease.
- Goal
- Improve walking with dopaminergic cells
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- iRegene Therapeutics Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 5 participants
- Conditions
- Parkinson Disease
- Interventions
- Human Dopaminergic Progenitor Cells
Plain-Language Summary
Goal: to test whether transplanting human dopaminergic progenitor cells can be safely tolerated and might restore dopamine in the brain enough to improve motor symptoms and reduce disabling OFF time in people with advanced Parkinson's. Approach: NouvNeu001 are lab-grown precursor cells placed into the brain by neurosurgery so they can mature into dopamine-producing neurons and supplement the effects of levodopa, participants stay on stable dopaminergic meds so investigators can watch safety and any added benefit. Eligibility: seeking people 30 to 75 years old with 4 to 20 years of PD, moderate to advanced motor disability (Hoehn-Yahr OFF 2.5,4, MDS-UPDRS-III >35) who show a clear levodopa response and are medically fit for brain surgery. This is a small phase 1 study enrolling about five participants, focused first on safety and feasibility with 12 months of follow-up.
Locations
- Cornell University Weill Medical College, New York, New York, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Human Dopaminergic Progenitor Cells. Goal: to test whether transplanting human dopaminergic progenitor cells can be safely tolerated and might restore dopamine in the brain enough to improve motor symptoms and reduce disabling OFF time in people with advanced Parkinson's. Approach: NouvNeu001 are lab-grown precursor cells placed into the brain by neurosurgery so they can mature into dopamine-producing neurons and supplement the effects of levodopa, participants stay on stable dopaminergic meds so investigators can watch safety and any added benefit. Eligibility: seeking people 30 to 75 years old with 4 to 20 years of PD, moderate to advanced motor disability (Hoehn-Yahr OFF 2.5,4, MDS-UPDRS-III >35) who show a clear levodopa response and are medically fit for brain surgery. This is a small phase 1 study enrolling about five participants, focused first on safety and feasibility with 12 months of follow-up.
- Who can participate?
- Participants must be between 30 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 1 year and 8 months.