FDA: 3 Hospitals OK for Stem Cell Therapy
THREE hospitals in metro manila have secured the approval of the Food and Drug Administration (FDA) to engage in human stem cell and cell-based therapies after meeting the safety, efficacy and quality standards set by Department of Health (DOH)
In a joint advisory signed by Health Secretary Janette Garin, the FDA said the first health facilities to receive such accreditation were The Medical City, Asian Stem Cell Institute and Makati Medical Center.
The hospitals were given approval to perform three applications of Stem cell therapy: hematopoietic stem cell transplantation, corneal resurfacing with limbal stem cells and skin regeneration with epidermal stem cells.
The certificate of accreditation for stem cell and cell based therapies was issued by the FDA and the Health Facilities and Services Regulatory Bureau (HFSRB). The two agencies conducted a review of the hospitals applications for accreditation and inspection for compliance with current good tissue practice and manufacturing practice the advisory said.
The review was conducted in compliance with DOH Administrative Order No. 2013-0012 issued in March 2013, which laid out the rules and regulations governing the accreditation of health facilities engaging in human stem cell and cellular therapies in the country.
The DOH issued the order in view of the growing popularity of stem cell therapies as alternative treatment to various diseases, and with some clinics and medical service providers claiming success in treating patients despite the limited published data from controlled clinical trials
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