Bangalore: Chennai-based LifeCell International will offer in April banking of menstrual blood that has recently been shown to contain stem cells, the master cells used in regenerative medicine, potentially adding another dimension to the debate about such research.
With exclusive licence for India from Florida-based Cryo-Cell International, which has developed the technology to harvest, process and store stem cells from menstrual fluid, LifeCell is currently field-testing the technology with Indian doctors.
Potential benefits: Processed stem cells before storage. New banks now offer to extract and store stem cells from menstrual fluid, embryos, bone marrow, body fat or adipose tissue and baby teeth. Photograph courtesy Cryo-save India
In culturally sensitive India, menstrual-fluid banking might prove a tough sell. “I know, it’s the craziest thing to do,” says Mayur Abhaya, executive director of LifeCell, which started private umbilical cord blood banking in India in 2004. But the potential benefits are so big that he isn’t shying away from crossing the initial roadblocks.
While umbilical cord blood stem cells, once processed and stored, cannot be multiplied at will, those from the endometrium (the uterine lining), collected through menstrual fluid, can be multiplied a million times if required, he claims.
Though the science is nascent, Firuza S. Parikh, an infertility specialist at Jaslok Hospital and Research Centre in Mumbai, who pioneered and set up the stem cell research at Reliance Life Sciences, or RLS, in 2001, doesn’t think the idea is “crazy”.
“I haven’t looked at their ground work but endometrium is a rich source of stem cells and I hope they do a pilot study on 100-150 Indian women to see if they can isolate the cell line and grow mesenchymal stem cells,” says Parikh. Mesenchymal stem cells are capable of differentiating into a variety of cell types.
Joining the more established banks of umbilical cord blood are new banks offering to extract and store stem cells from menstrual fluid, embryos, bone marrow, body fat or adipose tissue and baby teeth. Private banks call it bio-insurance, sceptics think it is capitalizing on people’s insecurity.
“We don’t subscribe to the idea of private banking of cord blood stem cells unless one has a family history of diseases like cancer, haemophilia, or other congenital defects,” says Anupam Sachdev, head of the paediatric haematology-oncology unit at Sir Ganga Ram Hospital in New Delhi, who also heads the same chapter at the Indian Association of Paediatrics.
Sachdev, who counsels at least one family a day on cord blood banking, advocates public repositories. “Private banking companies who claim curing 80-90% of diseases by cord blood stem cells are fooling the public”.
The irony, says Sachdev, is that most of the 8,000 transplants in the world using cord blood stem cells have come out of public banks, whereas most of the inventory lies with private banks. He has done two transplants using cords from the public arm of ReliCord, India’s first cord blood bank and an RLS initiative which offers both private and public banking.
ReliCord has supplied five stem-cell-enriched cord blood samples for transplants from its public repository, according to K.V. Subramaniam, president and chief executive of RLS.
But with only guidelines in place, and no law to enforce any regulatory regime, Sachdev fears “private banking could lead to murky business”.
Unlike the US and a few countries in Europe, there is no debate in India over the use of stem cells from embryos. However, while India has guidelines on the use of stem cells these are not legally binding.
Anticipating fears such as the ones expressed by Sachdev, the industry has begun innovating—it is offering both public and private storage but economics favours the latter. Public banks need either government or philanthropic support because cash flows into their kitty only when the blood is sold.
At its launch last year, Jeevan Stem Cell Bank in Chennai said 70% of its capacity would be for public storage. Similarly, StemCyte India Therapeutics Pvt. Ltd, a joint venture of Cadila Pharmaceuticals Ltd, Apollo Hospitals and California-based StemCyte Inc., is setting up a cord blood bank in Ahmedabad with both public and private services. Apollo’s hospitals across the country will eventually become collection centres.
Paving way: Mayur Abhaya, executive director of LifeCell.
“In signing an agreement with the Gujarat government in January 2007, we committed to providing cures for two blood disorders, thalassaemia and sickle-cell anaemia, which are highly prevalent in this region,” says Tushar Dalal, president of StemCyte India, even though this venture has been delayed by almost a year for reasons he “cannot disclose”.
But those not having public banking on the cards, such as LifeCell and Cryo-Save India Pvt. Ltd, are offering free storage to people who are in need of transplants but can’t afford to bank. Cryo-Save India is a subsidiary of the Netherlands-based Cryo-Save Group, Europe’s largest adult stem cell storage bank, whose fifth facility, costing €1.8 million (Rs11.66 crore), opened in Bangalore in December.
Even if experts think the therapies are not in sight in the near future, or that stem cells harvested with today’s methods might not work later, the industry reckons it is viable business. “The opportunities offered by stem cell research are limited only by imagination,” says Subramaniam.
Among others things, stem cell-derived cell types may provide tools for testing drugs which could lead to fewer, less costly and better-designed clinical trials, reducing the use of animal testing, he argues.
With at least eight banks operating in India and about 30,000 samples stored, including 17,000 at LifeCell and 5,000 at ReliCord, it might seem a crowded market.
It is not; the US has at least 90 banks with about one million samples, says V.R. Chandramouli, managing director of Cryo-Save India. Of 25 million annual births in India, 500,000 are potential customers, he believes. At Rs75,000 per umbilical cord (banked for 21 years), the math is easy: the market is worth Rs3,750 crore.
Most of these banks are relying on either parent companies and/or their collaboration with research institutions for eventually providing newer services in India. For instance, StemCyte has been facilitating thalassaemia transplants in Taiwan, and plans to do the same in India.
Chandramouli says the entry of multinationals, including Singapore-based CordLife Pte Ltd, will bring advanced technologies into the country.
Placenta, the standard source in cord blood banking, provides so-called haematopoitic stem cells which are used largely in blood disorders, but newer methods can extract more potent mesenchymal stem cells from the cord lining or adipose tissues discarded in liposuction (surgical removal of fat), he adds.
These promises notwithstanding, doctors remain wary of private banking. Targeted cryo-preservation has no role and Sachdev says that 20 years later embryonic stem cells may do the needful.
“I may change my tune a few years later, but today public banking is the way to go,” adds Sachdev, who says the corporate sector should fund public banks as there is no “serious thinking in the government”.
“We need 40,000 cords in public banks to be able to offer services to whoever needs a donor.”