drugset / Trial / NCT04434768

Evaluate the Safety and Explore Efficacy of Umbilical Cord Mesenchymal Stem Cells in Acute Ischemic Stroke

NCT04434768

Phase 1 Active not recruiting 10 enrolled Ever Supreme Bio Technology Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This study is a first-in-human assessment of safety of using umbilical cord mesenchymal stem cells (UCMSCs) in patients with Acute Ischemic Stroke via a combination of intra arterial (IA) and intravenous (IV) stem cell administration. The novelty of the current UMSC01 treatment study is the dual route of administration. Since dual administration of UCMSC via IA and IV had never been conducted in humans, there may be unknown risks to humans not predicted from the preclinical studies. However, the risk to patients in this trial will be minimized by rigorous adherence to the eligibility criteria, use of appropriate dose and concentration of stem cells, standardized techniques of stem cell infusion, and intensive patient monitoring during and after stem cell infusion.

Timeline

Start
2020-12-02
Primary completion
2026-02-28
Completion
2026-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject human umbilical cord mesenchymal stem cells Cell therapy Intravenous

Indications