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ACTIVE NOT RECRUITING
NCT07080775
PHASE1/PHASE2

The Safety,Tolerability, Efficacy of XS411 Cell Injection for the Treatment of Primary Parkinson's Disease

Sponsor: XellSmart Therapeutics (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

Summary

This Phase I clinical trial is designed to evaluate the safety, tolerability of a single dose of XS411 (derived dopaminergic neural progenitor cell injection) in patients with primary Parkinson's disease. This Phase II clinical trial is designed to evaluate the safety, tolerability and Efficacy of XS411 (derived dopaminergic neural progenitor cell injection) in patients with Parkinson's disease.

Official title: A Phase I/II Clinical Study on the Safety, Tolerability, and Efficacy of Stereotactic Intracerebral Transplantation of Human Allogeneic iPSC-derived Dopaminergic Neuronal Precursor Cells (XS411 Cell Injection) for the Treatment of Parkinson's Disease

Key Details

Gender

All

Age Range

50 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2025-08-05

Completion Date

2028-07

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

BIOLOGICAL

human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection

5.0×10\^7 cells/mL, injection, single dose

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China