India needs stem cell guidelines which can be amended biannually, said Dr Satish Totey, founder, chairman & managing director, Aureostem Research Pvt Ltd.

There cannot be a permanent set of guidelines. Every year we should make new draft guideline and seek public opinion. This must be discontinued immediately since valuable time and money are invested in the same. Instead it should be amended biannually, Totey told Pharmabiz.

Although the recent guidelines are comprehensive and may ensure patients get reliable and safe stem cell products in India in near future, yet the controversial section of this is Section 8. The section defines level of stem cell manipulation as minimum and major which is absolutely unnecessary and gives clear escape route to push unapproved stem cell for therapy by the clinicians, he said.

Desperate patients do not understand this terminology and often misled by the clinicians. For instance adipose derived stromal vascular fraction (AD-SVF) or bone marrow derived mononuclear cells (BM-MNC) which is minimal manipulated cells are being extensively used by the clinicians and giving impression to the patients that it do not require any clinical trials.

Now several clinicians use minimal manipulated cells for transplanting in retinas or in the brain without knowing its safety and efficacy. Much of what is being injected through minimum manipulated cells are not even stem cells. Moreover, one that come from fat or bone marrow are not capable of living in the human body for more than a day. There are several reports that patients become blind after such transplants, explained Dr Totey.

Another aspect which was totally ignored in the guideline is stem cell devices. Several clinicians use stem cell devices routinely in India which has limited approval from US FDA even for specific clinical conditions in the US. Therefore, such devices cannot be used in India. But clinicians are seen to mislead patients and giving impression that they have US FDA approval for stem cell therapy. This is a most dangerous procedure where, clinician can treat any condition without even having clinical speciality. For example, cosmetologists are now treating neurological or cardiac conditions. One of the key issues are oversight. But in these cases it is not just about desperate patients losing money but the genuine and tangible harms being done in the absence of oversight, he said.

Real progress in stem cell research and the development of cellular pharmaceuticals is not going to result from clinics making dramatic marketing claims. True progress requires extensive basic and pre-clinical research. It should be backed by carefully designed and properly conducted randomized clinical trials to ensure high-quality safety and efficacy data is generated.

Conducting such research in an ethical, scientific, and legal manner is difficult, costly, time-consuming, but necessary. More than 300 stem cell clinics that are operating in India are making dramatic advertising claims about stem cell treatments, but in most cases they have no evidence to support their hard-sell marketing, said Dr Totey.

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India needs biannual amendment to Stem Cell Rules, Section 8 of Rules controversial: Dr Totey - pharmabiz.com

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