NCT07212088

Stereotactic Intracerebral Injection of Allogenic IPSC-DAPs in Patients With Parkinson's Disease

Stereotactic Intracerebral Injection of Allogenic Induced Pluripotent Stem Cell-derived Dopamine Progenitor Cells in Patients With Parkinson's Disease

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: iCamuno Biotherapeutics Ltd. · Industry
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Parkinson's disease is a progressive neurodegenerative disorder characterized by high morbidity due to the limited regenerative capacity of dopaminergic neurons in the brain. Current drug treatments primarily manage symptoms but do not halt or reverse neuronal loss. Cellular replacement therapy has emerged as a potential strategy to restore dopaminergic function and address the underlying neuronal deficits. This study aims to evaluate the safety, feasibility, and efficacy of transplanting dopaminergic neurons into the brain to improve motor function and quality of life in patients with advanced Parkinson's disease.

Detailed description

Patients with Parkinson's disease will be treated with allogenic induced pluripotent stem cell-derived dopamine progenitor cells (iPSC-DAPs). These cells will be transplanted directly into the striatum to restore dopamine-producing capacity. Patients will be evaluated at 1, 3, 6, 9 and 12 months after transplantation for safety, feasibility, and efficacy.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
BIOLOGICAL	ALC01 therapy	A single dose of iPSC-DAPs will be administered into the putamen on each side of the brain

Timeline

• Start date: 2026-02-28
• Primary completion: 2027-12-15
• Completion: 2028-06-15
• First posted: 2025-10-08
• Last updated: 2026-02-11

Locations

1 site across 1 country: China