NCT07080775

The Safety and Tolerability of XS411CN Injection in Treatment of Primary Parkinson's Disease

A Phase I Clinical Study on the Safety and Tolerability of iPSC-Derived Dopaminergic Neural Progenitor Cell Injection Via Stereotaxic Brain Transplantation for the Treatment of Primary Parkinson's Disease

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a phase I clinical study to evaluate the safety and tolerability of human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection (XS411CN) via brain stereotactic transplantation for the treatment of primary Parkinson's disease. The study adopts a single-arm, open-label, non-randomized dose-escalation design to evaluate the safety, tolerability, and preliminary efficacy of stereotactic brain transplantation of XS411CN in patients with primary Parkinson's disease and explore the optimal recommended dose. 12 to 18 patients with primary Parkinson's disease are planned to be enrolled. On the day of cell transplantation surgery, the planned dose of XS411CN is transplanted into the bilateral putamen of the subjects by brain stereotactic technology. After receiving the XS411CN transplantation, the subjects will receive immunosuppressants. All subjects receive standard treatment at the same time. Each patient receives a safety observation period of 28 days after cell transplantation with XS411CN. This study adopts the traditional "3+3 " dose escalation method. The trial starts with a low dose and the dose will be increased gradually. Each subject will be closely observed for 7 days after surgery, and the dose-limiting toxicity (DLT) events that may occur within 28 days after the first transplant treatment will be evaluated.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection	5.0×10\^7 cells/mL, injection, once, 12 months

Timeline

• Start date: 2025-08-05
• Primary completion: 2026-04-30
• Completion: 2029-08-30
• First posted: 2025-07-23
• Last updated: 2025-09-11

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study