June 7, 2011

Stem cell industry is playing on the emotions of naïve patients and families promising a future which may not really exist

In January this year, doctors at a corporate hospital in Delhi claimed to have treated an Iraqi patient of paraplegia using stem cells. The patient, who had lost sensation in his lower limb, was said to be able to stand now.

Meanwhile doctors at another private hospital claimed to have treated victim of a bullet injury using stem cells. The girl, who is paralysed waist down, has not fully cured but she is believed to be "showing good progress and would soon limp back to life."

In recent years, stories of miraculous recovery with use of stem cells have made frequent appearances in the media offering hope in bleak situations.

Stem cells are the basic building blocks of our body either extracted from the patient’s bone marrow, cord blood or from suitable donors. They can also be derived from an embryo but that involves lot of ethical and moral issues. The unique quality of these cells is that they can take the shape of any organ or tissue.

This rebuilding feature of stem cells has led the scientists to target various diseases using them. From diabetes to Alzheimer’s, spinal cord injuries, heart ailments and blood disorders, stem cell therapy seems to be changing the dynamics of treatment.

A wide lacunae

Throughout India, there are around 15 big centres doing research as well as providing therapy via stem cells. At least six organisations have already reached advanced stages of clinical trials. Along with this, there are seven licensed banks operating in the country which store cord blood cells from the umbilical cord when the child is born. Unfortunately, here ends the good news.

Even though the success stories around stem cells grab big headlines, they are very few and far between. On the other hand, nobody gets to hear the failed stem cell treatments. After all, just like all other therapies, stem cells must be having an equal chance of failure but all we get to see are bright faces claiming to conquer a seemingly incurable condition.

The fact that the stem cell treatments are very costly rarely gets a mention. Systematic clinical trials to test the efficiency and safety of the method have not been done which is why stem cell therapy remains an experiment rather than being a mainstream modality. What allows such experiments to go on is lack of a legal framework.

Though success stories around stem cells grab big headlines, nobody gets to hear the failed stem cell treatments

Embryonic stem cell research, which is banned in most of the countries, continues to be done in India. It is believed that stem cells derived from embryos are the most potent but they have been shown to cause tumours when used on mice models. A Delhi-based doctor, who has not allowed peer review of her work, claims she has derived stem cells from embryos without any side effects and continues to treat patients, a lot of them foreigners. While her patients swear by the efficacy of the treatment, experts continue to criticise such unbridled use of embryonic stem cells.

Lack of control

At the heart of this debate lies the fact that the guidelines and regulations governing the practice of stem cell research and therapy in India are vague and non-binding. These guidelines issued by the Indian Council of Medical Research (ICMR) say that all centres doing stem cell research should have an institutional committee registered with the national committee.

Stem cell research may be conducted only after review by the scientific committee and an ethics review committee. Stem cell research towards a marketable product must also get approval from the Drugs Controller General of India. A committee should monitor the trial and conduct site visits when required.

However, since these guidelines are not legally enforceable, clinics and hospitals continue to thrive on false propaganda. Sadly, lack of any standard mechanism and established clinical trials even leave the genuine cases of stem cell success short of a well-deserved pat on the back.

Stoking the fire

When Sanjay Dutt decided to store the umbilical cord blood of his newborn twin babies last year, he joined a growing list of celebrities who have opted for cord cell banking. Kajol, Hrithik Roshan, Raveena Tandon, Farhan Akhtar, IT czar Aziz Premji, cricketer Ajith Agarkar, all of them have knowingly or unknowingly lent credentials to the claim of stem cell banks that storing the cord blood is a “biological insurance” for children.

The modest umbilical cord, which was never considered a useful thing after birth, has become the hot new possession in last six years with couples doling out large sums  of money because they are told storage of cord blood is a "must have" for every newborn. The market size of cord blood banking is estimated to be Rs 100 crore, growing at 30-40 per cent annually.

Undoubtedly, both the cord and the tissues expelled during childbirth provide a rich source of stem cells and scientists have found they serve as a form of protection against several diseases. However, there is still no proof that stem cells can be stored for 15 or 20 years without any damage or contamination. What stem cell players in India seem to be doing is make good use of absence of any law to regulate the industry. So, while nondescript clinics promise miracle cure, stem cell banks are making you believe in future which may not really exist.

Umblical cord and tissues expelled during childbirth provide rich source of stem cells but there is no proof that stem cells can be stored for 15 or 20 years withou damage

A bottomless pit

In September 2009, a Tamil Nadu-based hospital claimed to have cured an eight-year-old girl from thalassaemia by using umbilical cord blood stem cells harvested during the birth of her younger brother. In Delhi, a Pakistani boy was treated of a blood disorder using donor stem cells.

Success stories like these have given the much needed impetus to the trend of stem cell banking. However, there has been no case of these cells being used for self benefit, so the idea that everybody needs to store the stem cells of their children is too farfetched. A comparison of the trend in the west shows that most of the stem cell banks operating in Europe and US are public entities working like blood banks. They store cord blood cells donated by willing parents for research purposes or for treatment of patients in need.

Groups like American Academy of Paediatrics advise the parents to go for private banks only if there is a family history of disease or an older child lives with a condition that could potentially benefit from stem cell transplantation.

“Private cord blood banks target parents at an emotionally vulnerable time. It is not confirmed that transplantation using self donated cells rather than from a stranger is safer or more effective,” the academy maintains. In March 2008, a paper published in the journal Biology of Blood and Marrow Transplantation computed that the likelihood of a person using his own stem cells is 1 in 435.

Also, in most cases, stem cell transplants are successful only on children or young adults. The larger the size of the person, the more blood-forming stem cells are needed for a successful transplant and umbilical cord blood stem cells aren't adequate in quantity to complete an adult's transplant.

In most cases, stem cell transplants are successful only on children or young adults. The larger the size of the person, more the blood-forming stem cells are needed

However, lack of regulation in India means there is indiscriminate storage. And the reasons are pretty much clear. According to estimates, of the 26 million births in the country per year, almost 6,00,000 are prospective customers. To tap them, companies have entered into agreements with hospitals and fitness centres to catch gullible mothers-to-be during their visits to gynaecology departments and Lamaze classes.Anyone wanting to bank their newborn’s cord need to shell out about Rs 59,000- 1,20,000 for a period of 21 years. Easy monthly installments are offered to those who can’t pay the lump sum.

Stem cell banking is being depicted as an essential practice rather than a one-off requirement. And we are all falling in the trap.

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