drugset / Trial / NCT07084012
A Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of hUC-MSCs in Patients With AIS
Phase 2
Recruiting
60 enrolled
Shenzhen Wingor Biotechnology Co., Ltd.
Beijing Tiantan Hospital · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a Phase IIa clinical trial with a three-arm design that utilizes randomization, double-blinding, and placebo control. The primary objective of this study is to evaluate the efficacy of single and multiple intravenous infusions of hUC-MSCs injection in patients with AIS. The secondary objective is to assess the safety and tolerability of single and multiple intravenous infusions of hUC-MSCs injection in patients with AIS. The exploratory objective is to investigate the pharmacokinetic and pharmacodynamic characteristics of hUC-MSCs injection in patients with AIS.
Timeline
- Start
- 2025-08-27
- Primary completion
- 2026-03-05
- Completion
- 2026-12-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | human umbilical cord mesenchymal stem cells | Cell therapy | 1e+08 cells | Intravenous |
| Subject | human umbilical cord mesenchymal stem cells | Cell therapy | 2e+08 cells | Intravenous |