FDA: All but 3 stem cells

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Saturday, May 3, 2014

ALL except three types of stem cell treatment have been declared unlawful in the country by the Food and Drug Administration (FDA).

According to FDA Advisory No. 2014-033, the FDA related that it was not able to register any type of stem cell or human cells, tissues, and cellular and tissue-based products (HCT/Ps) aside from those already declared legal by the FDA last year.

"As of today, May 2, not one stem cell or HCT Product that applied for registration has been registered by the FDA for compassionate or clinical trial use, or for general use," said the FDA in the advisory promulgated Friday night.

"The use of HCT/P without the authorization or permission by the FDA is considered illegal in the country," it further said.

It noted that only the use of stem cells in hematopoietic transplantation; corneal resurfacing with limbal stem cells; and skin regeneration with epidermal stem cells has been found acceptable as standard healthcare procedure in the Philippines.

To recall, the FDA gave hospitals and other health facilities until August 31, 2013 to file their application for registration their stem cell or HCT Product at the FDA.

Because of this, the FDA stressed that all hospitals and health facilities must adhere to Republic Act 9711 or the FDA Act, which prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is unregistered.

Similarly, the health agency said all unlicensed practitioners from other countries and tourists, who visit the Philippines for leisure and medical needs, are being warned against using HCT/P without the authorization or permission by the FDA.

The FDA also urged the public to report the use of unregistered health products or any adverse effects following the use of HCT/Ps via e-mail atreport@fda.gov.ph.

Stem cell therapy, which is fast becoming popular in the country, is a type of intervention strategy that introduces new stem cells into damaged tissue in order to treat disease or injury as well as for cosmetic purposes. (HDT/Sunnex)

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