Indonesia’s BPOM Grants IND Approval For SCI To Conduct A Phase 2 Clinical Trial Using Stemedica Cell Technologies, Inc.’s Mesenchymal Stem Cells To Treat Acute Myocardial Infarction
5/27/2014 10:58:54 AM
SAN DIEGO--(BUSINESS WIRE)--Stemedica Cell Technologies Inc., a leading manufacturer of adult, allogeneic stem cells and stem cell factors, announces that its research partner The Stem Cell and Cancer Institute (SCI), a subsidiary of PT Kalbe Farma Tbk, Indonesia, received an IND approval in April 2014 from the Badan Pengawas Obat dan Makanan (BPOM, or the Indonesian FDA) for a Phase II study using Stemedica’s mesenchymal stem cells to treat acute myocardial infarction (AMI) in human subjects in Indonesia. The IND was filed by SCI with support from Stemedica Asia, a subsidiary of Stemedica, and was based on Stemedica’s United States FDA-approved Phase II AMI trial protocol.
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