FDA: No way spas can do stem-cell therapy

Health authorities on Saturday reissued warnings against health facilities and medical practitioners offering stem-cell therapies or related products, which promise to cure a range of diseases, arrest the aging process or even increase libido.

In an advisory, the Food and Drug Administration stressed that to date “not one stem cell or human cells, tissues, and cellular and tissue-based products (HCT/Ps) that applied for registration has been registered by the FDA for compassionate or clinical trial use or for general use.”

“The use of HCT/Ps without the authorization or permission by the FDA is considered illegal,” it said. The agency warned hospitals and health facilities of the provisions of the FDA Act of 2009, which prohibits the manufacture, use, advertisement or sponsorship of unregistered health products.

“This warning extends to all unlicensed practitioners from other countries and to tourists who visit the Philippines for leisure and medical needs.”

According to FDA acting director general Kenneth Hartigan Go, the FDA recognizes only hematopoietic (pertaining to the formation and development of blood cells) stem-cell transplantation, corneal resurfacing with limbal stem cells and skin regeneration with epidermal stem cells “as generally accepted standards of healthcare procedures.”

“If health institutions are doing these three procedures, they can continue because those are allowed,” Go said.

But the efficacy of the use of stem cells for the treatment of other diseases, such as diabetes, cancer and autism, among others, have yet to be proven, he said.

Go noted that while many spa centers and salons are advertising stem-cell therapy treatment and products, none of them have secured the FDA’s approval. “As of now, we have not accredited any health facility offering stem-cell therapy yet.”

Applicants with ‘deficiencies’

Several facilities had earlier applied for accreditation, but Go said many of them were asked to correct their “deficiencies.”

Submission of an application, he stressed, does not necessarily result in automatic approval.

FDA guidelines require that all stem-cell and cellular-based treatments offered in the country should first pass the agency’s standards for safety, efficacy and quality, he said.

Go urged the public to report those who continue to undertake stem-cell therapy procedures or who “mislead” their patients on the use of HCT/Ps as standard care for a specific condition.