NCT05901818

Safety and Efficacy of Autologous iNSC-DAP in the Treatment of Parkinson's Disease

Safety and Efficacy of Autologous Induced Neural Stem Cell-derived Dopaminergic Precursor Cells in the Treatment of Parkinson's Disease

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, interventional, single arm, open-label, clinical study to evaluate the safety and efficacy of the striatal transplantation of autologous induced neural stem cell-derived DA precursor cells in Parkinson's Disease patients.

Detailed description

Parkinson's Disease (PD) is the second most common neurodegenerative disease, caused by progressive depletion of midbrain dopaminergic neurons in the substantia nigra pars compacta. This clinical study will include the preparation of dopaminergic neural precursor cells derived from neural stem cells through reprogramming of patient's peripheral blood mononuclear cells (PBMCs), and transplantation of the obtained cells into the brains of PD patients by stereotaxic injection. Safety, tolerability, evidence of cell survival (using PET scan), and the efficacy on PD symptoms will be assessed at different time points up to 12 months post-transplantation.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Autologous induced neural stem cell-derived DA precursor cells	The autologous induced neural stem cell-derived DA precursor cells will be stereotactically implanted into the striatum of PD patients.

Timeline

• Start date: 2023-06-13
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2023-06-13
• Last updated: 2023-06-22

Locations

1 site across 1 country: China