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Evaluate the Safety and Explore Efficacy of Umbilical Cord Mesenchymal Stem Cells in Acute Myocardial Infarction

NCT04056819 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-09-19

No results posted yet for this study

Summary

This study is a first-in-human assessment of safety of using UCMSC in patients with AMI via a combination of IC and IV stem cell administration. The novelty of the current UMSC01 treatment study is the dual route of administration. Since dual administration of UCMSC via IC 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 Myocardial Infarction

Interventions

BIOLOGICAL

Allogeneic umbilical cord mesenchymal stem cells

UMSC01 cells will be one single IC infusion followed by one single IV infusion with 12 months of follow up after treatment.

Sponsors & Collaborators

  • Ever Supreme Bio Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Woei Shyu · Ever Supreme Bio Technology Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-05-27
Primary Completion
2021-08-02
Completion
2021-12-17
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 NCT04056819 on ClinicalTrials.gov