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The Stem Cell Business - Part 1

by Martine O'Callaghan

May 2, 2013

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Donate On April 22, 2013, the International Society for Stem Cell Research (ISSCR) issued a press releaseurging, "Italian lawmakers to heed concerns of scientists around the world about the premature practice of unproven stem cell treatments." The warning comes after Italy's health minister, Renato Balduzzi, allowed the continuation of unproven and potentially dangerous stem cell "treatments" on thirty-two terminally ill patients.

Though geographically specific, the statement reiterates fears raised in an ISSCR booklet published in 2008 that warns, "that stem cell therapies are being sold around the world before they have been proven safe and effective.” That earlier publication, aimed at potential patients and their carers, goes to great lengths to emphasise that these therapies being offered all over the world are “nearly all new and experimental.”Nonetheless, the warnings of this body and others have not deterred the desperate and/or vulnerable from seeking stem cell mediated miracles.

The very high price of false hope

Irving Weissman, director of the Institute of Stem Cell Biology and Regenerative Medicine at Stanford University, California, cautions that poorly qualified “stem cell clinicians” set up business in countries where medicine and medical procedures are poorly regulated. After treatment, the clinics just “let the patients go,” he mourns, “short of maybe $50-150,000 for a therapy that has no chance [of working].” This, he views as particularly lamentable because of the long distances some patients must to travel to access these procedures that are not available in the USA or Europe as they are yet to be proven safe or efficacious. Patients are, he says, “taken away from a family that needs them when they have an incurable disease. It is wrong.”

Foetal stem cells

Take the example of the case study presented in PLoS Medicine. A nine-year-old Israeli boy presented at a Moscow stem cell clinic with ataxia-telangiectasia (AT), also known as Louis Barr syndrome. The condition is incurable and progressive. Sufferers have uncoordinated movements, developmental delays, seizures and immune system deficits. The treatment which the clinic administered was to inject foetal derived stem cells into the boy’s cerebrospinal fluid. This they did at aged nine, ten and finally in 2004 at the age of twelve.

Seven months after the last injection, the child was admitted to Sheba hospital, Tel Aviv, with recurrent headaches. None of the symptoms of his AT had abated. To ascertain the cause of the headaches, an MRI scan was performed. It detected two tumours, one in his brain and one in his spinal cord. Luckily neither was cancerous " “such…treatments carry substantial risks and the potential for malignant transformation of transplanted cells.” Neither tumour matched the boy’s genetic markers. The transplanted stem cells had come from at least two donors, one of which was female. The report leaves the child in 2008, aged fifteen with tumours still growing in his spine and one compressing his brain stem. “Patients with AT are extremely sensitive to chemotherapy and radiotherapy,” it is noted in the paper. The team would “follow up the patient conservatively and repeat surgery [to remove tumours] only if indicated by clinical deterioration.”

Opponents of the use of " and research upon " embryonic cells might point to this paper as proof positive that this direction of research leads to a therapeutic dead-end. In 2011, at the World Stem Cell Summit, held in Pasedena, UC San Diego’s head of stem cell research Larry Goldstein contended that groups opposing the use of embryonic stem cells encouraged people to go abroad seeking unregulated therapies that do not use these types of cell. Goldstein insists that “it’s more unethical to encourage people to go to these offshore, snakeoil clinics and pay large sums of money for bogus medical treatments.” Echoing the ISSCR and Irving Weissman, he warns, “there really are charlatans out there, taking advantage of people’s desperation.”

Stem cells are not all alike

Therapies that do not make use of cell lines derived from aborted foetuses will often use stem cells taken from the patient’s own bone marrow or cell lines derived from umbilical cords of donors. Treatments are offered for neurodegenerative diseases such as Parkinson’s disease and other neurological conditions such as motor neurone disease, cerebral palsey and, perhaps most controversially, autism.

Not all stem cells are equal. Within a few hours of the first division of a fertilised or otherwise diploid (containing the full 23 pairs of chromosomes) egg, the resultant cells cease to be totipotent " able to make a whole new individual or zygote (such as in identical twins) to being pluripotent, able to make cells of any tissue in the zygote to which they are now committed to be a part. Multipotent stem cells are further differentiated and have the potential to become anyone of a limited number of cells and here we hit the problem of using bone marrow derived progenitor cells to treat neurological conditions.

Stem cells harvested from bone marrow can differentiate to become almost any kind of blood cell. They can never become a neurone (nerve cell) or any other type of cell found in the nervous system, such as schwann cells. Bone marrow derived stem cells certainly cannot become kidney cells as the next case study shows.

Another tragedy

Lupus nephritis is an autoimmune disease. The immune system attacks kidney cells as though they were alien to the body. The causes of this disease, that affects women more commonly than men, are unknown but genes are believed to play a part. Corticosteroids are used to reduce and prevent symptomatic swelling in arms, legs and fingers by suppressing the immune system.

Studies in the mid 2000s showed that bone marrow progenitor cells injected into the blood could, when combined with aggressive immunosuppressant medication, remediate some of the symptoms of lupus nephritis by “retuning” the immune system.

The New Scientist recounts the tale of female sufferer of this condition travelled to a stem cell clinic in Thailand after steroid treatment had proved ineffective. At the clinic, stem cells from her bone marrow were injected directly into her kidneys. Twelve weeks later her symptoms worsened and her over all health deteriorated and she required dialysis. Eleven months after treatment, her left kidney failed and had to be removed and after a further eleven months, the remaining one also failed and she died.

Study of her left kidney and post mortem study of the right showed lumps had formed on the surface and within the sites where the stem cells were injected. Though benign, tumorous tissue was also found in the adrenal glands and liver. Over time, had the patient lived, these could have become cancerous.

These two cases highlight the risks that individuals are taking with their lives and those of their children. Desperation can lead to poor decision making and this is why tight, global regulation of all branches of medicine, not just stem cell therapy, is required. Certainly, greater public understanding of scientific processes is necessary, too " but responsibility must also be shouldered by the media who hail each baby step forward in this area of medicine as a revolution and the end in itself.

by Martine O'Callaghan

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