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

NCT04434768 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-30

No results posted yet for this study

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.

Conditions

  • Acute Stroke

Interventions

BIOLOGICAL

UMSC01

There will be one dose of IV administration in patients with acute ischemic stroke, or one dose of IV administration followed by low or high doses of IA infusion for acute ischemic stroke with or without bridging therapy (i.e. Intravenous rt-PA thrombolysis or intraarterial thrombectomy) with 12 months of follow up after the first treatment.

Sponsors & Collaborators

  • Ever Supreme Bio Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chon-Haw Tsai, MD · Attending Physician of study site

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-02
Primary Completion
2026-02-28
Completion
2026-02-28
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04434768 on ClinicalTrials.gov