The Indian Council of Medical Research recently updated its guidelines to regulate the stem cell therapy industry in India. The council, which comes under the Ministry of Health and Family Welfare, is concerned that some clinics may be offering stem treatments for medical conditions that cannot actually be treated.
Stem cells are undifferentiated biological cells that are the foundation of all tissues and organs. A stem cell has the capacity to grow into a specialised cell – like a neuron or a type of blood cell. Stem cells extracted from human bone marrow, circulating blood or umbilical cord blood are used to treat serious medical conditions. For instance, in patients with cancers like leukemia and lymphoma, chemotherapy that targets cancer cells also destroys healthy blood cells. Such patients can have bone marrow stem cell transplants from healthy donors, which will allow their bodies to start making healthy blood cells again.
Some stem cell procedures – mainly haematopoietic stem cell transplantation which is transplantation of bone marrow, circulating blood or umbilical cord blood stem cells – have been well established and used to treat patients. Several other stem cell therapies that are only in research stages.
The ICMR first issued stem cell therapy guidelines in 2007, when the industry was just taking off in India. The two significant updates that the council has now made to the guidelines are to specify where stem cells for therapeutic use can be harvested from and which diseases stem cell therapy can be used to treat. The council has listed out 20 medical conditions in adults and 13 medical paediatric conditions for which stem cell therapy may be legally administered. Doctors may only administer stem cell therapy for conditions that are not on the list in a clinical trial. The council wants to ensure that doctors do not mislead patients into trying untested therapies.
The ICMR has also expressed concern over banking and use of umbilical cord blood. Many maternity hospitals now promote saving cord blood that contains stem cells after a birth, which might be used in case the child develops a serious medical condition that requires stem cell therapy. Most of these facilities that store umbilical cord blood do so for a high fee. There are few publicly funded umbilical cord blood banks in India.
But the ICMR guidelines say, “several private banks have come-up, that engage themselves in promotional advertisements offering storage of cord blood with the promise of future therapeutic use. Such advertisements are often misleading for the public and lack comprehensive and accurate information. So far there is no scientific basis for preservation of cord blood for future self-use and this practice therefore raises ethical and social concerns.”
While the use of umbilical cord blood stem cells for treatments of various haematological and immunological disorders have been well established, the ICMR points out that there is no scientific evidence on the clinical benefits of stem cells from cord tissue, placenta, tooth extract, adipose tissue, dental pulp, menstrual blood and olfactory ensheathing cells. Yet, many medical facilities offer to retrieve and bank these cells, raising concerns about commercialisation of such biological material.
In an interview to Scroll.in, Dr Geeta Jotwani, deputy director general of the ICMR who was responsible for compiling and editing this latest version of National Guidelines for Stem Cell Research, said that the Drugs and Cosmetics Act will soon be amended to specify penalties for doctors who are found violating the guidelines. Here are edited excerpts from the interview.
What is the main aim of these new guidelines?
The focus of the guidelines is to curb unethical practices in stem cell therapy in India. Some doctors are fooling patients by offering stem cell therapy for conditions for which there is no scientific evidence. We came across doctors who are promising to cure autism and other such genetic conditions by using stem cells. How can they expect to harvest stem cells from the patient who has a genetic condition and use these stem cells to treat them? If it is a genetic condition, the stem cells will also have the defect that is leading to the condition and such a therapy would be futile. At present, only those conditions mentioned in the guidelines are scientifically proven to be treated using stem cells and the rest is investigational. Guidelines clearly defines dos and don’ts keeping in mind the practices in the country – advertising in print and electronic media, who can conduct clinical trials, the responsibilities of doctors, investigators, institutes and the infrastructure and minimum qualification required. Doctors need to understand that these are biological entities and behave differently than chemical formulations, possibly causing irreparable harm to patients. The acts and rules covered are Drugs and Cosmetics Act, 1940, the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954, and the ethics and etiquette codes of the Indian Medical Council and the Advertising Standards Council of India. Basically, all the rules and regulations are in place. The need is to create awareness at the same time practice it.
An increasing number of parents are banking cord blood hoping that the stem cells derived from the cord blood will be helpful in treatment of diseases. However, there is a problem with the way cord blood banking is being marketed by some companies. There is no guarantee that when the child grown up, the stem cells harvested from the cord blood during his birth would prove of any use. There have been an instance where stem cells harvested from cord blood were sent to a university abroad and the researchers there found that it was not viable. What happens if the stem cells stored are not maintained properly and are not good enough for transplantation? What about the money invested by these parents?
So far there is no scientific basis for preservation of cord blood for future self-use and this practice therefore raises ethical and social concerns.
But will strict regulation hamper the discovery of new possible new treatments with stem cells?
We are not against innovation. ICMR has always been proactive in cautioning the scientific fraternity about the ethical conduct of biomedical research. ICMR and the Department of Biotechnology have been promoting research activities in the field. Both the agencies have been involved in establishing state of the art infrastructure facilities in the country.
These stem cell therapies that doctors are passing off as treatments are actually supposed to be part of clinical trials. There is already a regulatory mechanism in place, and the investigator needs to apply to the Central Drug Standard Control Organisation for permission to begin clinical trials. The guidelines clearly say that the participants of such clinical trials should give video consent.
In clinical trials, patients is participating to help the advancement of science cannot be charged. We have come across cases where doctors have charged lakhs of rupees for administering stem cell therapy, which is not even scientifically proven.
There are many doctors who claim that they have data of patients which show that stem cell therapy works. When they approached ICMR with their claims, ICMR initiated process of invited letter of claims last year in October. Those who have been selling big claims didn’t even turn up, which speaks about the authenticity of the promise being sold.
On the other hand, there are institutes that are trying to bypass the guidelines and regulations and offer premature therapeutic application stem cell by classifying it as an academic trial. They should know that there is nothing like an academic trial under the Drugs and Cosmetics Act, which governs these procedures.
Who is allowed to conduct stem cell clinical trials? What kind of infrastructure does a hospital need to conduct such clinical trials?
It is mandatory for all institutes and entities engaged in stem cell research to establish an institutional committee for stem cell research and register the same with national apex committee for stem cell research and therapy. They need to have an Institutional Ethics Committee registered with CDSCO. The infrastructure facility has to be certified under the CDSCO’s current Good Manufacturing Practices. The investigators involved need to have Good Clinical Practice certification. This is to inculcate good practices for the protection of human subjects involved in clinical trials.
Cord blood banking is legal only when these banks are registered with the Central Drug Standard Control Organisation.
Many banks in India also harvest stem cells from menstrual blood, cord tissue, placenta, tooth extract, adipose tissue and dental pulp? Is this allowed?
No. Right now only banks registered with the Central Drug Standard Control Organisation can store stem cells derived from cord blood but not even cord tissue. There is no scientific evidence to substantiate clinical benefits with the use of stem cells derived from cord tissue, menstrual blood, placenta, tooth extract, adipose tissue and dental pulp. Anyone offering to store stem cells derived from these sources is indulging in unethical medical practice.
Are there any side-effects of stem cell therapy?
We don’t know much about it. This is the reason we are advocating that any unproven therapy should undergo clinical trials. Clinical trials will not only tell us if the stem cell therapy is working but also give us data on side-effects or any adverse reactions. The embryonic stem cells and induced pluripotent stem cells [stem cells generated from adult cells] have tumorigenic potential which could be a major safety concern during clinical application of these cells.
What happens if a clinician is found to be in violation of the new guidelines?
The guidelines are an effort to keep up with the advancement in the science of stem cells and provide guidance to the stakeholders on the ethical practices. The Drugs and Cosmetics Act will be amended soon and it will deal with punishments in case doctors are found violating the stem cell therapy guidelines.