FDA on ‘alternative regenerative med’
This has reference to the article titled “Regenerative medicine—an alternative to facelifts and surgery” by Alex Y. Vergara (Lifestyle Wellness section, 6/17/14).
The Food and Drug Administration (FDA) has noted that the procedure—autologous platelet rich plasma (PRP) injections and cell therapy injections that involve cell extracts taken from sheep and rabbit fetuses featured in the article, i.e., getting the patient’s blood, processing it, and once the blood is processed, injecting its growth factors back to the patient’s anesthetized face—are analogous to stem cell procedure.
PRP and cell therapy injections are outside the initial three standard healthcare procedures recognized by the FDA, namely: hematopoietic stem cell transplantation, corneal resurfacing with limbal stem cells, and skin regeneration with epidermal stem cells.
The article also featured Swiss-made cellular products (known as MFIII Nano Cell Extracts and
Myopep Peptide Therapy) which are claimed to decrease fat buildup and to contour the body.
It must be stressed that the recognized skin regeneration procedure applies only to skin grafting for burn patients and not for any antiaging indications or aesthetic reason as featured in the subject news item.
To date, no human cells, tissues and cellular- and tissue-based products (HCT/Ps) are currently registered with the FDA; hence, any information on products and treatments which claims to use stem cells and the like—whether the information is in the form of an advertisement or information materials—is illegal as this could mislead the public on the standard of safety, efficacy and quality of the FDA-recognized HCT/P.
FDA highly recognizes the role of the media in promoting the consumer’s basic right to information. But it is our responsibility to give the consumers accurate facts and correct information to enable them to make an informed choice and be free from exploitation.
—KENNETH Y.
HARTIGAN-GO, MD,
acting director general,
Food and Drug Administration
As a journalist, I merely quoted Dr. Angela Gomez as she explained the logic behind what she offers. Based on my understanding, she doesn’t offer stem cell treatments, but Swiss-developed and -approved therapies containing cell extracts.
As for PRP injections, they have been around for years. I believe she isn’t the first beauty doctor to offer the so-called autologous procedure locally.
—ALEX Y. VERGARA,
Inquirer Lifestyle
