Stem cell therapy: Beware of unscrupulous practitioners

There is tremendous anticipation from stem cell research and therapy today as scientists pursue therapeutic applications in chronic and incurable diseases.

Some have compared the medical revolution it might bring to the dawn of the antibiotic era and chemotherapeutics. However, it is important to separate the possibilities from present capabilities in our world of information abundance.

Even though early results are guarded and require further studies, this may be lost on patients blinded by hope, who would understandably grasp at any new remedy offered to some very intractable and incurable disorders.

As with every new scientific advancement, there is a regulations lag as doctors and scientists come to terms with the research methodology, risks and applications along with the ethical implications.

The translation of research possibility to medical therapy is a process that requires time, scientific rigor and method including clinical trials, in order to bring a safe and efficacious treatment to patients. Any shortcut in this process could have disastrous results. Unfortunately, there are medical centers that are exploiting the lax regulations and patient’s desperation and are offering ‘stem cell therapy’ for a host of medical conditions in blatant denial of evidence based medicine.

The use of stem cells is based on the fact that these cells are widely present in different organs and tissues of the body and are responsible for the replacement of damaged or dead cells of that organ. With development of capability to isolate and transplant these cells, there emerged the possibility for therapeutic regeneration of diseased or dysfunctional tissues.

Bone marrow transplantation for growth of healthy blood cells is already in use for decades and is based on the ability of blood stem cells in the marrow to regenerate normal blood cells in disorders of the blood and immune system.

This is the only stem cell therapy that is currently approved as standard practice in medicine. All other stem cell therapy is deemed to be experimental as of now pending approval after clinical trials.

Unscrupulous practitioners have taken advantage of the promise of cure, partial information and inadequate oversight and are offering stem cell therapy for a variety of chronic and intractable disorders including parkinsonism, stroke, myocardial infarction, diabetic foot, spina bifida, cerebral palsy, multiple sclerosis and spinal cord injury among others.

The International Society for Stem Cell research (ISSCR) has urged governments and regulatory bodies to recognise the dangers of such unapproved therapy in vulnerable populations and released a white paper on the state of research in this field.

The Government of India responded with the Indian Council of Medical Research and Department of Biotechnology (ICMR-DBT) guidelines for Stem Cell research 2012. Under these guidelines, Institutional Committees for Stem Cell Research (IC-SCR) and Institutional Ethics Committees at the level of the health institution would report to a national apex committee for stem cell research and therapy. This would ensure that all clinical trials in this field are closely monitored and regulated.

Meanwhile, online advertisements of ‘stem cell clinics’ continue unabated. They promise ‘risk-free’, ‘simple injection’, ‘increased lifespan’ and ‘proven cure’ among other tall claims. The risk of treatment including massive immune rejection, infection and tumor formation is played down and testimonials are used to lure unsuspecting patients. One fallacy is that stem cells from one tissue source can be used to treat an unrelated tissue. It is unlikely that a single type of stem cell can treat unrelated diseases like diabetes and parkinsonism.

Of greater concern is the claims regarding embryonic stem cells due to their pluripotent nature. In reality, it requires complex interventions to coax embryonic cells to multiply into the desired cell type. Embryonic stem cell research is heavily restricted at present, in part due to the ethical implications of embryonic research. The immediate and long-term safety of such interventions is still to be studied. What appears to be promising in laboratory cultures may fail as therapy in animal models. Further, what works on an animal model may fail when tried in humans.

Patients stand to lose large sums of money and have their condition worsen when they try these untested remedies. Stem cell tourism has led to foreigners flocking to India to avail of unapproved therapies at the hands of conniving, self taught stem cell practitioners. Such unethical practice has been strongly denounced by neurosurgeons and hematologists in India and abroad.

In February 2010 the British company ReNeuron announced it had been approved to conduct a Phase I clinical trial of a neural stem cell treatment for stroke. The first embryonic stem cell-based treatment for acute spinal cord injury has been authorised by the US Food and Drug Administration (FDA) to move into Phase I clinical trials.

ISSCR has released a patient handbook on stem cell therapies to provide the scientific and ethical background for patients who may wish to participate in stem cell clinical trials. The Government of India ICMR-DBT guidelines have deemed any stem cell therapy outside approved clinical trials as unethical and not permissible.

In the exciting age of new technology, promising medical therapies attract investment for research but patients need to be cautious and rely only on evidence-based medicine in emerging therapeutics. The wait may seem long for patients with debilitating, incurable illnesses but scientists worldwide are hard at work to make ethical, safe stem cell therapy a reality.

(The writer is an anesthesiologist and bioethicist)