SAN DIEGO (Yosefardi) – 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.
The Biopharma Division of Kalbe is also working to file for a provisional IND for chronic heart failure using Stemedica’s mesenchymal stem cells, working closely with CardioCell LLC, a subsidiary of Stemedica devoted to treatment development and commercialization for cardiology.
In addition, Kalbe is reviewing the possibilities of filing the same IND for multisite Phase II trials in several other Southeast Asian countries, thus continuously building a reputation for rigorous regulatory compliance for stem cell therapeutics, in order to answer the needs of the ever-growing and aging population in the region. This IND approval from BPOM places Kalbe as leading Southeast Asia in setting an example for the rest of the region, which will bring healthy competition and awareness for regulatory guidelines and policies for stem cell therapeutics.