NCT07084012

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

A Phase IIa Randomized, Blinded, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in the Treatment of Acute Ischemic Stroke (AIS)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shenzhen Wingor Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Stroke is a disease with high incidence, disability rate, and mortality rate, ranking as the second leading cause of death globally and the leading cause in China. Acute ischemic stroke (AIS) accounts for approximately 60%-80% of all strokes. The most effective treatments for AIS are revascularization therapies within the time window, including intravenous thrombolysis with tissue plasminogen activator (t-PA) and mechanical thrombectomy. Although t-PA thrombolysis is effective, it can cause reperfusion injury, exacerbating a series of inflammatory damages. Additionally, the success rate of thrombolysis and thrombectomy is closely related to the onset time. The time window within 4.5 hours or 6 hours is considered effective for rescuing the ischemic penumbra, and only a minority of AIS patients can receive thrombolytic therapy. Some patients have contraindications to thrombolysis, and endovascular treatment is only suitable for large vessel occlusion. Furthermore, in China, low public awareness of early disease recognition, insufficient prehospital emergency capabilities, in-hospital emergency delays, and other factors lead to delayed AIS treatment and a low thrombolysis rate. Studies have shown that mesenchymal stem cells can reduce the infarct area and alleviate blood-brain barrier damage by regulating the microenvironment of damaged brain tissue, alleviating inflammatory responses, and promoting angiogenesis, neurogenesis, and neurovascular repair. This study aims to evaluate the efficacy, safety, and tolerance of single and multiple intravenous infusions of hUC-MSCs injection in the treatment of AIS patients.

Conditions

• Acute Ischemic Stroke AIS

Interventions

Type	Name	Description
DRUG	hUC-MSCs treatment (high dose)	2.0×10\^8 cells per infusion, single administration on D0. Infusion of cell medium placebo on Day 7 (±2 days), and Day 14 (±2 days).
DRUG	hUC-MSCs treatment (low dose)	1.0×10\^8 cells per infusion, 3 administrations, on Day 0, Day 7 (±2 days), and Day 14 (±2 days)
DRUG	Placebo	Cell medium, 3 administrations, on Day 0, Day 7 (±2 days), and Day 14 (±2 days)

Timeline

• Start date: 2025-08-27
• Primary completion: 2026-03-05
• Completion: 2026-12-05
• First posted: 2025-07-24
• Last updated: 2025-09-29

Locations

1 site across 1 country: China