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RECRUITING
NCT06147986
PHASE2

Evaluate the Efficacy and Safety of Allogeneic Umbilical Cord Mesenchymal Stem Cells As an Add-On Treatment for Acute ST-elevation Myocardial Infarction (STEMI) Patients

Sponsor: Ever Supreme Bio Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

This phase IIa study is to identify the efficacy and safety of IC(intracoronary) and IV(Intravenous) administrations of UMSC01 in patients with STEMI . This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. The previous Phase I, open-label, single arm, single center study was conducted to evaluate the safety and to explore the efficacy of UMSC01 in subjects with STEMI via intracoronary administration followed by intravenous infusion. This first-in-human Phase I study of UMSC01 was completed on August 2nd, 2021. Among 8 subjects enrolled, no subjects experienced treatment-related TEAEs.

Official title: A Phase IIa, Dose-Escalation Followed by Randomized, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of Allogeneic Umbilical Cord Mesenchymal Stem Cells As an Add-On Treatment for Acute ST-elevation Myocardial Infarction (STEMI) Patients

Key Details

Gender

All

Age Range

20 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2023-09-24

Completion Date

2027-06-24

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

BIOLOGICAL

Allogeneic umbilical cord mesenchymal stem cells

UMSC01 cells will be IC infusion followed by IV infusion with 24 months of follow up after treatment.

OTHER

Control group

Standard-of-care for STEMI

Locations (1)

China Medical University Hospital

Taichung, Taiwan