This is with reference to the article titled “Stem cell transplantation in India: tall claims, questionable ethics” (1).

As the director of Nichi-In Centre for Regenerative Medicine, Chennai, I would like to state that the use of the term “unethical” to refer to our institute is unjustified considering our credentials, conduct and values; further, it has been used without any verification or communication with us on what exactly we have been doing.

1. I would like to refer to the Indian Council of Medical Research’s (ICMR’s) national guidelines on stem cell research and therapy published by the ICMR and available online (2). The guidelines state, in clause 13, that stem cell therapy for everything except bone marrow transplantation should be done with the approval of an institutional ethics committee or Institutional Committee for Stem Cell Research and Therapy (IC-SCRT). Further, Directorate Controller General of India is necessary for marketable products. It is unfortunate that the above guidelines of the ICMR have not been cited as a reference in the article. It is only based on these guidelines that one can say whether one is ethical or not.
1. Till date Nichi-In has been following the above guidelines strictly and ours would have probably been the first institute to have informed the IC-SCRT apart from the Institutional Ethics Committee (IEC).
2. Though the National Accreditation Committee for Stem Cell Research and Therapy (NAC-SCRT) mentioned in the ICMR guidelines has not yet been formed, and even though the guidelines do not state that the IEC/IC-SCRT meeting proceedings should be reported to the ICMR, Nichi-In has been regularly sending the proceedings of the IEC/IC-SCRT to the ICMR without fail. This demonstrates our willingness to be transparent and our commitment to adhere to the guidelines and follow ethical principles.
3. Though it is not mandatory, we invited the ICMR expert team to visit us. The team visited us on May 7, 2007 and went through our credentials including our protocols and publications. The team consisted of Dr SS Agarwal, Dr Dipika Mohanty, Dr PB Seshagiri and Dr Geeta Jotwani.
4. All our research and clinical work is presented in meetings such as those organised by the Indian International Society for Stem Cell Research (ISSCR). Though there are no stem cell research forums in our country we are conducting regular annual meetings. We have been taking the pain to organise an annual symposium every October since our first in October 2006. At this symposium, all our work is presented to a gathering of physicians and scientists moderated by experts from the ICMR as well as eminent people from clinical and research arenas outside our collaboration.
5. Though the GMP/GTP for cell processing/stem cell research guidelines have not been published in the above mentioned ICMR guidelines, we have been following the best protocols to see that cleanliness, sterility, particle count, equipment calibration, entry procedures, etc are maintained as required for cell culture procedures.
2. As far as the relationship between us and the hospital(s) that avail of our services is concerned, I would like to stress the following matters of concern:
1. We get approval from the head of the hospital saying that their ethics committee has approved the clinical study. We also sign a memorandum of understanding demarcating the responsibility between us and the hospital. In all such applications the relevant physicians are the principal investigators and handle the patients after obtaining their informed consent.
2. We do not advertise and we never send any of our personnel to any hospital for marketing. We do not encourage, support or provide our cell processing expertise for clinical indications other than those which have evidence of such usage in peer-reviewed publications.
3. When we asked the visiting ICMR expert team about our responsibility when a non-GCP (Good Clinical Practice)-compliant hospital wants to avail of our services, they replied that we were responsible until the specimens leave our premises; after this, the responsibility is with the hospital (the present GCP guidelines in India do not require a laminar air flow system that is mandatory for an operation theatre in which when cells packed in a Class 100 environment is opened, contamination cannot be ruled out).
3. Nichi-In has been working with several institutes on research using stem cells/progenitor including the Institute of Pathology of the ICMR where we have been working on finding solutions to several diseases prevalent among the lower socioeconomic sections of the country such as persistent corneal ulcers, burns etc. We do this as a commitment to society with an aim of developing cost effective remedies; we want to see that these newer technologies should not remain accessible only to the affluent. The unjustifiable remarks made in the article will only dampen the spirits of people like us who have been working on projects that will help the masses in the country.

If the publications relevant to the various applications of bone marrow stem cells are required, we can send the same in hard copy to your postal address.