NCT04340609

Stem Cell in Acute Myocardial Infarction

Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Acute Myocardial Infarction

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: PT. Prodia Stem Cell Indonesia · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study will perform UC-MSCs transplantation in 2 groups and 1 control group with standard treatment. Each group consists of 5 subjects. In the first group UC-MSCs will be transplanted via intravenous (IV) route and the second group via intracoronary (IC) route. The IV group will receive 2 million cells/kg for each subject and the dosage of IC group is 50 million cells for each subject. All groups will be observed until 1 year.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
BIOLOGICAL	Mesenchymal Stem Cells	The UC-MSCs from a donor will be cultured in a clinical grade laboratory with xeno-free medium. Maximum passage of expanded-UC MSCs was VI and doubling population is less than 30. To assure the quality of our expanded-UC MSCs at ProSTEM the following tests are done: cell adherence, cell surface marker, in vitro differentiation, cell viability, sterility, Mycoplasma, endotoxin, and karyotyping.

Timeline

• Start date: 2019-03-11
• Primary completion: 2021-04-08
• Completion: 2022-04-08
• First posted: 2020-04-09
• Last updated: 2022-06-14

Locations

1 site across 1 country: Indonesia