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

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.

Timeline

Start

2019-05-27

Primary completion

2021-08-02

Completion

2021-12-17

Publications

• Results Hsiao LC, Lin YN, Shyu WC, Ho M, Lu CR, Chang SS, Wang YC, Chen JY, Lu SY, Wu MY, Li KY, Lin YK, Tseng WI, Su MY, Hsu CT, Tsai CK, Chiu LT, Chen CL, Lin CL, Hu KC, Cho DY, Tsai CH, Chang KC, Jeng LB. First-in-human pilot trial of combined intracoronary and intravenous mesenchymal stem cell therapy in acute myocardial infarction. Front Cardiovasc Med. 2022 Aug 9;9:961920. doi: 10.3389/fcvm.2022.961920. eCollection 2022.

Drugs

Indications