By offering unproven therapies, a Texas biotechnology firm has sparked a bitter debate about how stem cells should be regulated. Ann McFarlane is losing faith. In the first half of 2012, the Houston resident received four infusions of adult stem cells grown from her own fat. McFarlane has multiple sclerosis (MS), and had heard that others with the inflammatory disease had experienced improvements in mobility and balance after treatment. The infusions — which have cost her about US$32,000 so far — didn’t help, but she knew that there were no guarantees. It is McFarlane’s experience with Celltex Therapeutics, the company that administered the cells, that bothers her. She was told that she had been enrolled in a study to test the cells’ efficacy, but received almost no information about it. And although it wasn’t exactly a secret that the treatment had not been approved by the US Food and Drug Administration (FDA), Celltex, based in Houston, Texas, assured its clients that it was within its rights to provide it. But Celltex was forced to halt treatments in October, and in November a legal battle broke out over who owned the cells still being stored by the company. For weeks, McFarlane was uncertain whether her cells were being grown and stored properly. Although Celltex has told its customers that it has settled the dispute, McFarlane has her doubts. “I am not confident that the cells are viable and safe,” she says. “I probably will not feel comfortable using these cells.”
For the past decade, people such as McFarlane have searched far and wide for clinics offering to deliver on the promise of adult stem cells. Unlike embryonic stem cells, their use does not require the controversial destruction of an embryo. Yet although adult stem cells are claimed to ameliorate a wide range of disorders, they have not yet been shown to do so conclusively in clinical trials in the United States. Relying on customer testimonies and company promises, patients have travelled to clinics in places such as China, Costa Rica, Mexico and Japan to receive them from unregulated, often unaccredited, laboratories, driving a boom in stem-cell tourism. According to Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis, at least ten clinics offer treatments in the United States. Turner and others have questioned the quality of the cells that these firms provide, and several outlets have been forced to stop providing treatments. CellTex has been one of the most visible. Established in 2011, it offered therapies for conditions as varied as arthritis, back pain, MS and Parkinson’s disease. It produced its cells in a 1,400-square-metre, state-of-the-art facility in Sugar Land, Texas, that was registered with the FDA, and — the company claimed — had strict quality control. Although the company flouted federal regulations, which deem such cell therapies to be biological drugs, it adhered to state rules, which had recently been tailored to bolster the stem-cell industry. But even with the support of Texas governor Rick Perry — Celltex’s first patient — the company had to stop offering treatments in the United States.
March 5, 2013
Original web page at Nature