The darker side of stem cells | Nature

An investigation by _Nature_ has found that patients in Texas are receiving unproven stem-cell treatments. The state and the company involved need to ensure that they follow FDA guidelines.

Stem cells offer the hope that one day they will be able to cure a huge range of disorders. But too many people are promising those cures to patients now, long before there is any evidence

that they work. These claims are potentially misleading at best, and at worst could be downright harmful. This week, _Nature_ raises important questions about one company that works with

adult stem cells: Celltex Therapeutics in Houston, Texas. _Nature_'s investigation, reported on page 13, suggests that the company has supplied adult stem cells to Texas doctors who

offer unproven treatments to patients, and that the company is involved in these treatments. One doctor claims that the treatments are part of a clinical study run by Celltex and that the

company pays him US$500 a time to inject the cells into patients, who are charged up to $25,000 for a course. The US Food and Drug Administration (FDA) considers it to be a crime to inject

unapproved adult stem cells into patients. David Eller, chief executive of Celltex, denies that the company is involved in treatment procedures, but would not comment on _Nature_'s

findings about how its cells are used or answer questions about them. Celltex has the backing of state governor Rick Perry, who has tried adult-stem-cell treatments himself. And the company

recently recruited Glenn McGee, editor-in-chief of the _American Journal of Bioethics_, to be its president of ethics and strategic initiatives. McGee, whose move from the academic world to

industry sparked a controversy over a perceived conflict of interest (see _Nature_ 482, 449–450; 2012), promises that Celltex will set up and run clinical trials, and will do so according to

strict ethical standards. But he too would not answer _Nature_'s questions on whether the company knew about the unapproved clinical use of its stem cells or whether he considered such

activity to be ethical and legal. > Texas officials should take the FDA's regulatory power over stem > cells more seriously. There is an ethical paradox here. How can Celltex

propose clinical trials for stem-cell treatments while at the same time it is, according to a doctor involved, paying physicians to use those treatments — or supplying cells to doctors who

would no doubt use them — in the clinic? Shouldn't clinical trials be done before a treatment is given to paying patients? Conversely, if a treatment is known to be safe and effective

enough to be prescribed routinely, and for a sizeable fee, what is the point of doing a costly clinical trial? The questions do not stop at Celltex. The governor-appointed Texas Medical

Board is set to launch regulations in April to tighten controls on the use of 'investigational agents' — such as stem cells that do not have FDA approval. But the board is

simultaneously offering an alternative route by proposing that those who want to use adult-stem-cell treatments need either FDA approval or simply the approval of a local institutional

review board. Texas officials should take the FDA's regulatory power over stem cells more seriously. In its discussions, the state's medical board revisited the well-trodden ground

of whether adult-stem-cell procedures — in which cells are taken from a patient, processed and cultured, before being reintroduced — should be under FDA jurisdiction, or whether they are

akin to simple skin grafts from one part of the body to another, which do not require validation in an FDA-approved clinical trial. The FDA can help to clarify these matters. A sensible

first step in the new state regulations would be a requirement for any firm that plans to inject processed stem cells into patients to contact the FDA, which can advise on whether federal

rules — the same federal rules that have already been used to arrest stem-cell practitioners and to stop a company pushing unapproved treatments elsewhere — apply to what they are doing.

Once past that step, Texas could move on to develop its own safety regulations. If the Texas Medical Board were to act according to its stated pledge to protect patients, then it would make

clear the need for clinical validation of adult stem cells before use and would rescind the medical licences of any doctors in breach of rules on using unapproved treatments. If Celltex

truly wants to help patients, then it should refuse to supply stem cells for medical procedures until those procedures are properly proven to be effective. And if the company is serious

about demonstrating clinical effectiveness itself, then it should start by contacting the FDA about what needs to be done. RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE

CITE THIS ARTICLE The darker side of stem cells. _Nature_ 483, 5 (2012). https://doi.org/10.1038/483005a Download citation * Published: 29 February 2012 * Issue Date: 01 March 2012 * DOI:

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