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RECRUITING
NCT07084012
PHASE2

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

Sponsor: Shenzhen Wingor Biotechnology Co., Ltd.

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-08-27

Completion Date

2026-12-05

Last Updated

2025-09-29

Healthy Volunteers

No

Interventions

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)

Locations (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China