Crackdown urged on ‘rogue’ stem cell clinics
Stem cell clinics promising costly cures for everything from Parkinson’s disease to spinal cord injury grossly exaggerate the cells’ benefits and gravely underestimate the potential risks, warn researchers.
The clinics, most of them in China, India and Latin America, solicit customers over the Internet and typically charge about $21,500 for treatments that infuse “stem cells” into the blood, brain or spine.
But there is scant evidence the therapies work, Timothy Caulfield and his colleagues at the Health Law Institute at the University of Alberta note in a report released Wednesday, along with a call for a crackdown on “rogue” stem cell operations.
The clinic websites make bold claims about cures and feature testimonials from satisfied customers. But there’s a “big over-estimation of benefit and a huge down-play of risk,” says Caulfield. “The available peer-reviewed research simply does not support the claims.”
His team could find no legitimate medical studies to support using stem cell therapy to treat Parkinson’s or Alzheimer’s diseases. The same was true for treatments offered for dozens of different ailments and disorders by 19 clinic websites assessed, the team reports in the December issue of the journal Cell Stem Cell, which also lays out new guidelines to try to curb use of the unproven treatments.
“Too often rogue clinics around the world exploit patients’ hopes by offering unproven stem cell therapies, typically for large sums of money and without credible scientific rationale, oversight or patient protections,” says the International Society for Stem Cell Research, representing “professional” stem cell researchers.
Scientists and their famous supporters, such as the late actor Christopher Reeve, have extolled the potential curative power of stem cells for years, saying one day it may be possible to use the cells to repair and replace many diseased cells and tissues. The high-profile promises have helped generate research funding for academic medical researchers, but have also spawned dozens of cell-therapy companies and clinics, which solicit patients over the Internet.
But medical and research authorities say stem-cell therapies are years away from routine clinical practice. The new guidelines aim to steer patients into legitimate treatments and stem cell clinical trials in which the risks and benefits are clearly laid out.
“Stem cell research holds tremendous promise for the development of novel therapies for many serious diseases,” says neurologist Dr. Olle Lindvall, at the University of Lund in Sweden, co-chair of the international task force that developed the guidelines posted on the stem cell society’s website. “However, as clinicians and scientists, we recognize an urgent need to address the problem of unproven stem cell treatments being marketed directly to patients.”
He and his colleagues would like rogue clinics put out of business.
“Regulators have a responsibility to prevent exploitation of patients in their jurisdictions, and where necessary, to close fraudulent clinics and take disciplinary action against the doctors involved,” Dr. George Daley, director of the Stem Cell Program at Children’s Hospital Boston, said in a statement released with the new guidelines.
The report from the Edmonton group highlights the freewheeling approach taken by clinics trolling for customers online. The websites offer treatment for dozens of different ailments using stem cells isolated from blood and embryos, some even claiming to use cells from aborted fetuses and animal tissues. The treatments offered commonly entail infusing cells through the blood stream, but some use “deep injection” of cells into the brain. Others put the cells directly into the spine.
By Margaret Munro
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