Stem cell therapy for burns, not aging, says FDA
September 30th, 2013 5:40 amMANILA, PhilippinesStem cell therapy should only apply to skin grafting for burn patients and not for anti-aging purposes, according to the Food and Drug Administration (FDA).
Up to now, there is no evidence that stem cell therapy has anti-aging effects, said 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 health care.
Asked if this meant anti-aging stem cell therapies would not be allowed in the Philippines, Go said: It means that if the health claim is for burn patients, requirements that need to be submittedlike clinical trial reportsare expected to be complete, whereas if the claim is for anti-aging, then the requirements may be more extensive and intensive considering that products for anti-aging claims are still controversial.
Facility accreditation
The FDA said it had been continuously collaborating with the Department of Healths Bureau of Health Facilities and Services (BHFS) in accrediting facilities that deal with human cells, tissues, and cellular and tissue-based products (HCT/Ps), laboratory and therapeutic activities or services.
As of Sept. 24, 51 facilities have applied for accreditation, and 11 of these have been inspected by the BHFS, the FDA said.
No automatic approval
Submission of an application, however, does not necessarily result in automatic approval.
The FDA guidelines require that all stem cell and cellular-based treatments offered in the country should first pass the agencys standards for safety, efficacy and quality.
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Stem cell therapy for burns, not aging, says FDA