The Korea Food and Drug Administration (KFDA) is expected to finalize all procedures needed to permit the sale of "Hearticellgram-AMI," a stem cell therapy for acute myocardial infarction, on July 1, according to the KFDA officials.
The therapy was developed by FCB-Pharmicell, which specializes in developing stem cell drugs for incurable diseases. The company is headquartered in Seongnam, south of Seoul.
The drug has passed all three procedures, including safety and validity tests, needed for its approval. The other remaining steps will likely be completed soon, the officials said.
Hearticellgram-AMI takes somatic stem cells extracted from the patient`s own body that are then cultured and directly injected into his or her damaged heart. (*)
Editor: Kunto Wibisono
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