A cell culture There has been an explosion of news suggesting a bioethical scandal in recent days. A quick Google search for “CellTex scandal” will produce over 7,000 results, discussing the accusations by two University of Minnesota professors of an illegal stem cell operation at the Houston-based company, CellTex Therapeutics. Ironically, the accusations arose after the Texas Governor, Rick Perry, made mention of a recent procedure involving his own stem cells and back pain. Perry may be more responsible for the recent crusade against CellTex than anything else because of his high profile. So, the question becomes, is this really a scandal or is the bioethics community making an example out of Celltex?

The controversy lies within the relationship between Perry, his physician who is also co-founder of CellTex, CellTex’s ethicist (Glenn McGee), the bioethics whistle blowers, and the FDA. Some news reports have introduced even more players to the mix, as if there weren’t enough already, including overseas company and CellTex partner, RNL Bio, McGee’s successor (Mrs. McGee), and the American Journal of Bioethcis (AJOB). The list goes on. (See this article for a detailed account of the story and players.)

CellTex provides a banking service for people who wish to preserve stem cells for future medical use. This type of service is not an FDA-regulated area because there is no 'product.' Or is there?

Texas Governor Rick Perry, the controversial patient Perry became a customer, probably because his physician is the co-founder of CellTex, and elected to have stem cells harvested from his own fat cells and preserved for future use. All the hype is about whether or not CellTex violated any laws or regulations when they dispersed Perry’s adult stem cells to his physician who subsequently treated Perry’s back pain using experimental stem cell therapy. Keyword: experimental.

Whether or not Perry (or anyone else) chooses to participate in experimental stem cell therapy is his own choice, is it not? In a letter to the FDA, CellTex’s lawyers stated the company does not treat any patients which clearly distinguishes it in the FDA’s eyes. In fact, it is not uncommon practice for doctors in the US and abroad to engage in experimental stem cell therapy for a variety of indications.

What’s raising even more red flags is the resignation of one of CellTex’s ethicists, Glenn McGee. Any ethicist who resigns amidst a potentially bioethical conflict automatically looks guilty. You might as well admit to unethical practices; however, ethics are generally not on the FDA’s radar. The FDA is concerned with safety; bottom line.

The FDA has never evaluated an orthopedic use for stem cells. Perry had his stem cells injected into his spine for back pain. I suppose the gray area lies with the physician who administered the treatment because his physician is also the co-founder of CellTex. And CellTex’s partner company in South Korea, RNL Bio, has been under fire for questionable practices involving potential stem cell-related deaths. That’s where the bioethical whistle blowers come into play.

The FDA does regulate stem cells. The FDA cautions consumers considering stem cell therapies to ask if the facility and testing are part of an FDA-regulated study because substantial health risks can occur during experimental stem cell therapy treatments as a result of cell manipulation following harvesting. These risks include the development of tumors. Illegal stem cell practices generally involve the marketing and distribution of a stem cell-derived product. As of today, there are no FDA-approved stem cell products, with the exception of Hemacord, a cord blood-derived product indicated for very specific blood disorders.

FDA involvement can certainly drive up the cost of drug development, and slow the process of getting potential cures to the marketplace. But, FDA-regulated studies generally produce safer, higher quality, and more effective food and drug products. I believe the FDA’s stance on stem cells sufficiently explains their position on cases like the one involving CellTex and Gov. Rick Perry.

My opinion? CellTex hasn’t done anything illegal. Whether or not their service should be regulated by the FDA is up for debate. When Perry followed the advice of his physician and had CellTex harvest his stem cells, he acknowledged the inherent safety risk associated with experimental therapies.