FDA on alternative regenerative med

Philippine Daily Inquirer

This has reference to the article titled Regenerative medicinean 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 procedureautologous 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 patients blood, processing it, and once the blood is processed, injecting its growth factors back to the patients anesthetized faceare 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 likewhether the information is in the form of an advertisement or information materialsis 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 consumers 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.

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FDA on alternative regenerative med