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 the 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.

In a study conducted by the DOH to determine the services and equipment available in hospitals nationwide, it was found that five hospitals and some ambulatory surgical clinics were providing stem cell services to patients for various indications.

In its 2013 order, the department said it was imperative that a regulatory framework be developed and strengthened to ensure patients’ access to safe and quality health facilities engaging in human stem cell and cell-based therapies in the country.

In the FDA-HFSRB Advisory No. 2015-001, patients are advised to seek stem cell therapies only in the accredited facilities. “Any other therapies or establishment offering stem cell therapies outside of those mentioned under this joint advisory are not authorized and should be avoided by the public,” it stressed.

Health facilities offering such services but are not accredited by the FDA and HFSRB must be reported to either of the two agencies for appropriate regulatory action through the following channels: report@fda.gov.ph or (02) 8571900, or hfsrb@doh.gov.ph or (02) 6517800 local 2525, 2502 to 2504.

In 2013, the Philippine Medical Association warned Filipinos against foreign doctors who come to the country to perform “xenogeneic” or animal-based stem cell therapy in five-star hotels in Metro Manila.

That same year, the deaths of at least three lawmakers were linked to the stem cell treatment they had received abroad.