With over 20 million births in a year and new research activities taking place in the area of extraction of stem cells from the human body, the prospect is immense for stem cell banking industry in India.
According to the Stem Cell Global Foundation, the stem cell banking business is poised to grow more than 35 % over the next year to Rs 140 crores.
Umbilical cord and cord blood banking is probably one of the most important long-term investments.
While six years ago, when a handful of companies started offering expecting parents the option of preserving their newborn child's stem cells for future use, the response was tepid. Now with the growing awareness on the potential life-saving power of stem cells, more and more people are turning their attention towards stem cell banking.
According to estimates from the medical community, an average of 24,000 couples opt for the procedure every year across India. This is a far cry from the initial years when the annual figure averaged just about 300.
Cord blood stem cells have the potential to give rise to other cell types in the body, and can be used to treat life-threatening diseases such as leukaemia and blood diseases. With a shelf life of 21 years, stem cells are seen as a form of health insurance.
Commenting on the prospects and problems of stem cell banking in India, Rajesh Sharma, Managing Director, Cryo-Save India says,“Stem Cell Banking”, a phrase that was unheard of at the beginning of the century in India, sounds more familiar today with over a dozen stem cell banks owned by multinational and domestic Indian companies operating in various cities in the country. But, it is still not common for expecting parents to opt for the concept of banking the stem cells of their newborn or for others to consider storage of stem cells from other sources in the human body. The main reason for this is the lack of awareness of the concept and the benefits of the stem cells in case of certain life threatening diseases.
With over 20 million births in a year and new researches in the area of extraction of stem cells from other sources in the human body, the prospect is immense for this industry in India. Whereas, it is agreed that there is a lot of research in progress in many areas, the fact that the stem cells have the characteristics of saving lives from dreaded diseases cannot be undermined , he adds.
However according to him,the biggest challenge the industry faces today is lack of stringent regulations like in developed countries such as the US and members of the Europe Union, lack of awareness amongst common man and reluctance from medical fraternity to promote this new concept without sufficient information available in the public domain on the success of the therapies even though there are successful transplants conducted both locally and globally.
The clients today have access to the information on recent development in the technology and hence, the comparison is on quality of the service provided and credibility of the service provider. The pricing is no more the only decision-making criteria, he points out.
Entry by global players like Cryo-Save, having a wide geographic spread across the world and having over a decade’s experience with a proven track record of acceptability in different countries and their regulatory bodies is further boosting the potential in the market. Thus, contributing to the growth of the stem cell banking industry in the country.
“The benefits from stem cells are so immense that we advocate that the people should store the cord blood and tissue cells with either a family bank or a public bank but not dispose it as a bio-waste. And, the medical fraternity has to play the guiding role in India, as in the developed western countries, in informing the general public about the opportunity to opt for such service”, he concludes.
Says Dr Jyothsna Rao, director, International Stemcell Services Ltd, India’s cord blood banking sector has witnessed growth in terms of new facilities. But there is a huge issue of unregulated pricing norms and unethical promotion of stem cells harvested from the cord blood which needs to be handled.
Despite the Drugs Control General of India (DCGI) constituting the regulations a year ago, the guidelines on cord blood banking are yet to be enforced. This has led to the prevalence of aggressive marketing by cord blood banks and erring doctors engaged unscrupulous practices to collect, store and administer treatment protocols, she bemoans
There are currently around 15 centres in India undertaking the cord blood banking services. Some of the well-known names are the Chennai-based Lifecell, Kolkata-based Cord Life, Mumbai’s Reliance life Sciences, Cryobanks India in Gurgaon Bangalore-based Cryo Save and International Stemcell Services. In addition, there are many small banks which lack the infrastructure to store cells but are still engaged in collecting cord blood from the hospitals.
The growing interest by the parents to preserve the cord blood for future medical emergencies has led to the increase in the number of facilities which has also resulted in stiff competition among the players in the sector, she says.
“Doctor referrals have been the sole point of business for the cord blood banking services. But now with the access to hospital database, companies directly contact the to pregnant patients to bank the cord blood. This has a serious implication on the method of the cord blood collection immediately after the delivery. Some facilities collect only 50ml cord blood but a minimum of 120 ml is required for good harvest of stem cells, points out Dr. Jyotsna.
Therefore need of the hour is ample training of not only doctors but nurses to ensure right collection practices and quality harvesting processes, she adds.
Another issue is the cost, which varies between Rs. 75,000 to Rs. 1.5 lakh for a period of 21 years with credit offer of Rs. 2,000 per month. This is where guidelines for cord blood banking are required, she adds.
At around Rs 50,000 for the extraction and preservation of cord blood stem cells for a 21-year-period, the procedure is not a cheap option. Interestingly though, a majority of couples opting for this treatment are the educated middle-class, who are willing to bear the monetary pinch.
According to Dr. Abhijit S. Bopardikar, Pathologist, Director of ReeLabs,stem cell industry is growing at a fast pace in the absence of regulations. This gives unscrupulous companies a chance to mislead prospective customers. Empty promises are made and customers are lured into stem cell banking without actually understanding what they are getting into.
The stem cell banking also has to deal with a very important factor and that is logistics. Attention must be given to the fact that the sample must be processed as early as possible within six to eight hours for best results though most companies process the sample within 48 hours, whereby, the results may be compromised, says Dr. Bopardikar
Another challenge that this industry faces according to him is creating awareness amongst the prospective mothers, though it is much better than what it was a couple of years back.
According to him,stem cell banks should follow certain practices which reflect the true nature of the business. Stem cell R & D must be undertaken in a big way to create stem cell therapy for patients with no hope disorders. Several clinical trials are required and the research on stem cells should be done in a scientific manner, he opines.
Says Dr. Prosanto Chowdhury, Medical Director, Cordlife India Ltd, “Stem cell banking is an essential component for availing the future therapy. If today the stem cells are not stored for directed use, tomorrow when it is required, it may not be available at hand, precious time will be lost in procuring it, at a prohibitive cost, with no guarantee of its work capacity”.
According to him,the problem of stem cell banking is firstly the dearth of donors who come forward for collection and storage of their sibling’s umbilical cord and blood. Problem is not with the affordability but with the access to the correct information which will help them to take the right decision, at the right time. Imparting the right knowledge, for an informed decision, is very vital. Educating physicians, on the banking and use of stem cells and the expansion of the therapeutic horizon, is essential for them to transfer the same knowledge to their patients, to root out misconceptions and inculcate the sense of security of availing the advantage of regenerative medicine in the not so far future.
The dearth of stem cells according to him can be solved by recruiting more donors, and by removing the stigma associated with placental and umbilical cord blood and tissue. This can be achieved by donor education and motivation, armed with correct knowledge. The doctors should be educated with proper scientific data on recent updates such that they can motivate their patients. Research and development that is required should be funded by the Government and NGOs and red tapism attached to clinical trials should be loosened, but, not compromising with the ethics or outcome.
The way research is progressing, with acceptance of stem cell banking becoming slightly better and the awareness level on the rise will make available more stem cells, with the prospect of being predictably used in another decade. Pharmacotherapeutics will take a back seat and the definition of therapy and medicines are set to be redefined in the very near future,opines Dr Chowdhury.