FDA: Only 3 Hospitals OK for Stem Cell Therapy one of them is the Asian Stem Cell Institute
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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