While ICMR prohibits the use of stem cells, extracted from the umbilical cord for treating irreversible and degenerative diseases, unproven cures continue unabated due to lack of any law
By Dinesh C Sharma
It’s an eye-catching television spot featuring film star Aishwarya Rai Bachchan. The commercial is different because here, the Bollywood actor is not endorsing a beauty care product or a health tonic or a new brand of shampoo, but is advo-
cating a service that deals with a human-derived biological product.
The commercial starts with the baby shower (gode bharai) ritual of a would-be mother, with family members surrounding her and presenting gifts. Everybody is surprised as Aishwarya suddenly appears on the scene, greets the pregnant young woman with an unseen gift and says that it is for the security of her unborn child. Then, she addresses viewers, telling them the benefits of cord blood (blood in the placenta and the attached umbilical cord after childbirth, from which stem cells are extracted) banking and how stem cells could cure debilitating ailments in the child. She further adds that as a mother she has preserved her child’s cord blood.
The nicely woven story board of this commercial has all the necessary ingredients— family bonding, human emotion, drama, gla-mor, science and commerce. The only problem is that it violates the guidelines of the Indian Council of Medical Research (ICMR) on stem cell research and therapy.
The guidelines are the only official framework available on the subject and ICMR is very clear on such commercial advertisements. It states: “There are ethical concerns about the promotional advertisements by private banks offering storage of cord blood for possible future use. Such advertisements are often misleading for the public and lack comprehensive and accurate information to the consumer. It may be mentioned that there is no scientific basis for the preservation of cord blood for future self-use and this practice is not recommended.” Since these are only guidelines—and not a law—no action can be taken against companies indulging in such commercialization of human fluids.
ICMR has recommended that its guidelines be converted into a law so that cord blood banking and stem cell business could be regulated legally. The process has been going on for more than a decade now. After several years of consultation and debate, the council, along with the Department of Biotechnology, released “Guidelines for Stem Cell Research and Therapy” in 2007. It was expected that hospitals and doctors dealing with stem cells would stick to this framework, which was not mandatory but voluntary. Ignoring this, unscrupulous doctors started offering premature stem cell treatments commercially and even started attracting foreign medical tourists. This forced ICMR to revise its guidelines based on new findings.
The revised guidelines were published in 2013 with a significant change—the word “therapy” was dropped from the title to emphasize that only stem cell research would be allowed and not any therapy. This makes it amply clear that ICMR views all stem cell-based treatments being offered as experimental and research work, and not any the-rapy. “The word ‘therapy’ has been omitted from the title to stress the fact that stem cells are still not a part of standard of care, hence there can be no guidelines for therapy until efficacy is proven”, the council has clarified.
The 2013 guidelines cover only stem cell research, both basic and translational, and not therapy. The guidelines clearly state that “any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine, and not offering it as therapy. In accordance with this stringent definition, any use of stem cells in patients outside an approved clinical trial shall be considered as malpractice.”
Despite a clear statement from the apex medical research body that “there is no conclusive proof of safety or therapeutic efficacy of stem cells in any condition yet”, commercial stem cell therapies continue to be offered for curing untreatable diseases. That’s why now ICMR wants these guidelines converted into a law.
Experts feel that exploitation of patients by doctors offering unproven stem cell treatments should be stopped urgently. “Thera-peutic benefits (of stem cells) that doctors are touting are all experimental. And for experimental research, hospitals or doctors are not supposed to take money but they are charging lakhs of rupees for a single intravenous dose of stem cells,” points out leading bioethics expert and former ICMR scientist Dr Vasantha Muthuswamy. Scientifically designed and responsible research on stem cells should, however, continue as per the guidelines which classify stem cell research into three categories—permitted, restricted and prohibited.
A layered ethical review system has also been laid down in this framework. Besides institutional ethics committees, permissions are now required from Institutional Committee for Stem Cell Research and National Apex Com-mittee for Stem Cell Research and Therapy. The role and functioning of these committees is also being streamlined. However, only responsible research institutes, hospitals and companies are going through such review. Commercial outfits are still going scot-free because there is still no law yet.
Companies engaged in stem cells and cord blood are taking advantage of loopholes in the regulatory framework. While commercial stem cell therapy has been termed unethical and premature by ICMR, cord blood banking has been legalized under the drug control regime. Cord blood banks may be opened with approval from the Drug Controller General of India.
Claims that stem cells harvested from cord blood can be used for treatment of diseases in future is only partly true because there still are questions about the viability of these cells beyond a few years as well as about the potential of using stem cells to treat diseases. Should healthy families succumb to such promotion of cord blood banking when the likelihood of ever using the blood may be rare and its future medical uncertain? What’s the guarantee that biological fluids stored in commercial banks won’t be misused for unethical research? What about the rights of donors? These are valid questions, given the prevailing scenario in the assisted reproduction or fertility market, where commercial transactions involving human eggs, sperm and womb are aplenty.
Given the past record of government agencies with stem cell guidelines, it may take another couple of years before the guidelines become a law. Till then, gullible patients as well as healthy parents will continue to fall for questionable stem cell therapies and cord blood banking.
All about stem cells
Stem cells are the body’s raw material—cells from which all other cells with specialised functions are generated. Under the right conditions in the body or a laboratory, stem cells divide to form more cells called “daughter cells”. No other cell in the body has the natural ability to generate new cell types.
Stem cells can be obtained from embryos that are three to five days old. These are pluripotent stem cells, meaning they can divide into more stem cells or can become any type of cell in the body. Such cells can be used to regenerate or repair diseased tissue and organs, but their use is mired in ethical concerns.
Adult stem cells are found in small numbers in most adult tissues, such as bone marrow or fat but their ability to give rise to various cells of the body is limited. Now scientists have altered properties of adult stem cells to make them behave like embryonic stem cells through genetic reprogramming. These are called induced pluripotent stem cells.
Another source of stem cells is amniotic fluid in addition to umbilical cord blood stem cells. These stem cells also have the ability to change into specialized cells. More studies are needed to understand their potential.
Stem cell therapy—or regenerative medicine—promotes repair of diseased, dysfunctional or injured tissue using stem cells or their derivatives. Specialized cells, grown in a lab, can be implanted into a person. For example, if the person has heart disease, the cells could be injected into the heart muscle. The healthy transplanted heart cells could then contribute to repairing defective heart muscle.
Doctors have performed stem cell transplants, also known as bone marrow transplants. In stem cell transplants, stem cells replace cells damaged by chemotherapy or disease. Or they can be injected to fight some types of cancer and blood-related diseases, such as leukemia. These transplants use adult stem cells or umbilical cord blood.
Premature use of stem cells for therapy before obtaining adequate data on their safety has the danger of tumor development due to capacity of stem cells for unlimited proliferation, possibility of genomic changes and chances of immune rejection.
(Source: Mayo Clinic, ICMR)