Clinical Trial

A Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of hUC-MSCs in Patients With AIS

Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-03-05 -> 2027-05-31 2026-07-30
minor Completion pushed: 2026-12-05 -> 2028-12-30 2026-07-30
Trial Details
NCT Number NCT07084012
Lead Sponsor Shenzhen Wingor Biotechnology Co., Ltd.
Collaborators: Beijing Tiantan Hospital
Conditions Acute Ischemic Stroke AIS
Enrollment 60 participants
Start Date 2025-08-27
Primary Completion 2027-05-31 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-29