Fresh cell therapy outside FDA-recognized standard health care

This has reference to the news item titled “Nation’s rich fight aging with stem cell therapy” (Front Page, 11/7/13).

The Food and Drug Administration (FDA) has noted that the stem cell procedures featured in the news item—i.e., harvesting the patient’s stem cells from their own fat and injecting them into their blood and harvesting cells from unborn sheep to be injected into a patient’s muscle, known as fresh cell therapy—are outside the initial three standard health care it recognizes, namely: hematopoietic stem cell transplantation, corneal resurfacing with limbal stem cells, and skin regeneration with epidermal stem cells.

It must also 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.

As of date, no human cells, tissues and cellular and tissue-based products (HCT/Ps) are currently registered with the FDA. Hence, any information for more affordable products and treatments claiming to use stem cells, be it in the form of an advertisement or informative materials are illegal, as this could mislead the public on the standard of safety, efficacy and quality of the HCT/Ps recognized by the FDA.

The role of the media in promoting the basic consumer right to information is highly recognized by the FDA. It is our responsibility to give the consumers accurate facts and correct information needed for them to have an informed choice and be free from exploitation.

We thank the Inquirer for being our partner in promoting consumer protection.

—KENNETH Y. HARTIGAN-GO, MD,

acting director general,

Food and Drug Administration