Law & Ethics
Worldwide and in particular in the Asian countries where cell therapy is more developed the Ethical basis of using cell therapy as a treatment form is based on the Declaration of Helsinki on the ethical principles for medical research involving Human subjects formulated by the World Medical Association in which it is stated that :-
“In the treatment of an individual patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician`s judgments it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate, made publicly available.”
So as per the Helsinki Declaration , cell therapy can be used for those conditions for which there is no other treatments available. At the NeuroGen BSI we strictly adhere to and follow the above Helsinki declaration.
In India for all these years the Regulatory authority for Cell therapy and Research has been the Indian Council of Medical Research (ICMR). They have formulated draft guidelines in the years 2003, 2007 and 2013 . These are available at www.icmr.nic.in. Although these cover many aspects of cell therapy and research, briefly speaking they had put the use of embryonic stem cells in the restrictive category and the use of umbilical cord cells as well as adult stem cells in the permissive category. There is a requirement for the formation of an Institutional Committee for Stem Cell Research and Therapy (ICSCRT). This has now been recently modified to an ICSCR. In any case these are guidelines and they as of now have not yet been passed by Parliament as a legally binding law or bill. In the recent past the Drug Controller General of India (DCGI) has also taken up responsibility of this field and had put up the proposed new guidelines for public opinion on their website in February 2014. As is obvious from all the above is that there are a lot of grey areas. However in the next few months /years we should hopefully see something more definite and progressive happening on the regulatory front that will be in the interest of patient care.
In summary what this means in our view is that ethically for conditions for which there is no other treatment option available or all available treatment options have exhausted we can offer cell therapy as a treatment option on compassionate grounds. However it is important that all clinical results are documented and published. From a regulatory viewpoint if minimally manipulated autologous adult stem cells, such mononuclear cells, are being used (like we do at NeuroGen BSI) then approval is needed from the Institutional stem cell committee / Ethics Committee. Special informed consent is important before doing this treatment.