Seoul: South Korea`s drug safety agency will likely approve a stem cell therapeutic drug early next month in what could be the world`s first move to permit the sale of a stem-cell medicine, officials said today.
The Korea Food and Drug Administration (KFDA) is expected to finalise 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 specialises in developing stem cell drugs for incurable diseases.
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.