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Stem Cell: Tied Up In Knots

It is only when the regulatory hurdles are lifted, will the Indian stem cell sector know the true potential of its research

Dr Firuza Parikh was one of the most discussed names in the media in India in the early 2000. Considered the face of India’s stem cell research then, Parikh was the founder- director of Mukesh Ambani-promoted Reliance Life Sciences. Speaking at one of her felicitation functions in Mumbai in 2001, she called Reliance Life Sciences’s (RLS) high profile project a “new millennium initiative” and said, “With a team of 50 scientists, this initiative is already in the global scenario in its first eight months.”

Of course, India made headlines as one of the emerging global hubs for the most ‘promising’ stem cell research at the turn of the century and it was not only RLS, but many other Indian companies and institutions also jumped on the bandwagon with high expectations and tall promises then. But the hype didn’t last, and many professionals, including Dr Parikh, left the industry sooner.  

The culprit: an obscure regulatory environment and a big quandary over the much-touted stem cell-based treatments. As a result, many who had entered the arena with heavy investments focusing on development of cell therapies as well as cell banking finally landed in a stalemate. Today  there is a complete overhaul that is taking place in the industry and all the models are being reworked.
 
Unique Challenges 

In the early part of this century, India was among the few active countries in the field of regenerative medicine and had a head start. “However, with obscurity in the regulations, proposals for clinical trials have been languishing for years,” says K.V. Subramaniam, President and CEO, RLS. “Conse-
quently, India has become a laggard in the world order in the domain of regenerative medicines,” he adds.

According to industry estimates, close to a billion dollars went into this business between 2001 and 2010 in India and about two times of this was expected to flow in from foreign investors. The government too spent at least Rs 300 crore (around $8 million, then) through Department of Biotechnology. Between 2002 and 2015, at least 30 institutions ventured into stem cell research and banking.

Meanwhile, the controversy around the use of embryonic stem cells hijacked the enthusiasm to a large extent in the industry. This had rippling effects on the formulation of regulatory framework and the process as well. Initially, most of the highly rated projects in the stem cell research were carried out on embryonic cells.

To make matters worse, lack of regulations also led to mushrooming of stem cell clinics with questionable treatment claims. Even as the stem cells in the umbilical cord helped finding a non-controversial alternative to embryonic-based cells, the dilemma continued with the prevailing uncertainties about treatment claims.

While the research-oriented entities were concerned mainly due to ambiguity in regulatory procedures and delayed approvals for trials, the banking companies found hardly any use for stored samples. Umbilical cord cells in a private bank is typically restricted for use of the child whose cord blood is collected, and may be for the siblings too. Plus, a shortage of public banks that can provide donor cells to the needy resulted in cell-based therapies becoming almost a non-starter in the country.

“The concept of private banks for stem cells was a misplaced strategy. They could not contribute much to the progress of the treatment,” says Ahmedabad-based hemato oncologist Sandeep Shah. “Most of the successful stem cell transplants in India were allogenic (using donated stem cells), so the private banks are yet an unproven concept in this context,” he adds.  

As science author and clinical cardiology and research head at Medanta Heart Institute, Sanjay Mittal says India faces some unique challenges in streamlining actions in this promising science. “Given India’s science, tax regimes, regulation, supporting industries and financial markets are at a different stage of evolution to that of the developed economies, India faces unique challenges in the fluid arena of stem cell globalisation,” Mittal wrote in a 2013 report.
 
Changing Scenario
Private banking is being completely revamped in India. Same is the case with many of the initial product development works as well. For instance, the country’s largest stem cell banking company, Chennai-based LifeCell International has changed its concept to community banking, by which matching samples are shared with anyone in the subscriber community. Similarly, therapy development companies like RLS have scrapped several of their initial projects to start fresh with completely new targets in line with the new regulations. While some see this as a new opening, they want to do it with caution and without hype.

With the changing regulatory environment and the transforming business models, industry insiders are optimistic about its future. LifeCell, with over 2 lakh units of cord blood stem cell samples collected from its subscriber parents, is better placed to implement its new sample sharing model. This will ensure the stem cells in its storage are used across its subscriber community, including the parents and siblings of the baby, whose cord blood is collected, and also with other subscribers and family on a donor-recipient matching basis.

“We have already moved to the community banking model from February,” says Mayur Abhaya, CEO, LifeCell. “This will not only ensure a wider utility for the stem cell units in our storage but also enable sharing therapeutic benefits among the community members,” he adds. The company also claims that the new model could drastically lower the cost for its subscribers. Besides, the company is working on the placental tissue, which has applications in wound care, burn, surgical, orthopaedic, spine, sports medicine, pain management, ophthalmic and dental treatment through allograft.

The pioneer stem cell R&D player RLS, is now aggressively looking at developing a range of stem cell-based therapies and tissue engineered products addressing unmet medical needs. With approvals already in place for three stem cell-based products, for treatments in the areas of Type 2 diabetes, Graft versus Host disease, Ischemic Limb Disease, the company seems confident in the stem cell therapy market along with its public stem cell bank that gets donor cells for a larger patient benefit programme. RLS already offers limbal stem cell therapy for damages to the limbal area of the eye and conjunctival stem cell therapy for damages to the conjunctiva with its technology for growing adultstem cells through autologous (sourcing cells from the patient’s body itself) therapy.

Bengaluru-based Stempeutics, which later tied up with drug maker Cipla as an equity partner, had, in 2016, received limited approval from the DCGI for its stem cell-based product Stempeucel for treatment of Buerger’s Disease. Stempeutics, which was the first company in India to get the approval for a stem cell product for the disease, says it took nine years to develop this product.  
   
Since this biotechnology revolution that offer several possibilities such as tissue growth of vital organs like liver, pancreas and many more diseases for which no effective treatment still exists, besides giving symptomatic relief for disorders, including Multiple Sclerosis, Parkinson’s, Alzheimer’s, severe burn, spinal cord injury, India can’t afford to lose out in this new healthcare arena. While the regulatory regime seems more robust now, the industry is hopefully returning to the game.  
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“Applicability Is A Big Issue”

There was over hype around stem cell ventures, but nothing much happened in the last decade and now the models are being changed. Why?
The slowdown happened due to the dismally low number of transplants. Although we have done fairly well as a private stem cell bank with over 2 lakh samples in storage already, there were just 45 transplants (across India and abroad). According to an estimate by ICMR, the country needs 2.5 lakh stem cell samples to find the match for at least 90 per cent of the requirement. There are less than 5,000 samples currently available in the public repositories. This has prompted us to move into the community model.

Is affordability another issue?
Yes. Affordability, awareness and applicability are the major issues. Stem cell samples, if matched with the receiver, alone cost about Rs 20 lakh, as there are no adequate samples available in public currently. The samples stored with private banks were available exclusively to the subscriber till now. The high cost for collection and processing was also another issue. While these charges have already come down significantly in the last few years, the total cost will be further lowered once the applications are more.

How are you planning to take LifeCell forward in this yet evolving space?
We are focusing on some other new but complementary areas too. While the community model in stem cell banking is key, there is a diagnostics service chain for mother, foetus and new born. The other complementary businesses that we will enter soon include placental tissue collection and processing, transplant clinics and development of stem cell-based biologicals.


'Obscurity In Regulations'
Why did India lag behind in the stem cell arena?
In the early part of this century, India was among the few active countries in the field of regenerative medicine and had a head start. However, with obscurity in the regulations, approvals for clinical trials have been languishing for years. Also, the absence of a clear regulatory environment in India has led to mushrooming of stem cell clinics and questionable claims and practices. Thus, while prospects for regenerative medicine are promising, the regulatory environment has been a dampener.

Has it affected pioneers like Reliance Life Sciences as well?
It is true that we too had to shelve some of the projects due to the regulatory dilemma. However, RLS has been a pioneer in Asia in the area of regenerative medicines and it continued its focus on developing a range of stem cell-based therapies and tissue engineered products addressing unmet medical needs.

What is the prospect that you see for the sector?
With increasing focus on advanced curative solutions, stem cell therapeutics has generated a lot of excitement. It is estimated that about 200 million patients in the world are in need of stem cell therapies for diabetes, osteoporosis, congestive heart failure, Parkinson’s, Alzheimer’s, spinal cord injuries, birth defects, cancers and organ transplants.



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