Just a week before Shobhana Suresh was to give birth to her second baby she chanced upon an advertisement that struck a chord with her, an umbilical one. A company presentation later, she signed up for an unusual deep freeze insurance plan — one that said if certain cells were harvested from the blood in the umbilical cord after it was snipped off and banked in temperature-controlled cryogenic vaults, they could be handy as perfectly-matched regenerative cells for her to-be-born-son to fight a potentially endless list of ailments that could strike in the future.
When Rishi entered the world a few days later, blood from the cord that may have otherwise been discarded was put into a cryobox and flown to Chennai where LifeCell, a branch of an American company that commercially banks cord blood, has its Indian headquarters. There it would be processed and stored, for a fee.
Homemaker Shobhana’s baby is among this unusual bank’s 3,000 clients who include the offspring of celebrity parents such as cricketer Ajit Agarkar and actress Raveena Tandon. And LifeCell is not the only one offering such services.
In the new age of medical marvels, reality, it seems, can hardly keep pace with imagination. Human biotechnology meets genetics and the lab is now in our everyday life. In India, this is especially true of the growing kinds of tissue and organ depositories. Time was when banks in the health lexicon implied blood banks or eye banks. Now there are multi-tissue and bone banks such as the one run by the Tata Memorial Hospital Tissue Bank, Mumbai (TMHTB), a public non-profit institution, and commercial futuristic cell banks including Lifecell and Cygenics, apart from repositories such as Reliance Life Sciences that have opened shop in recent years.
For a customer what it means is simply this: there may be a ready stock of bone or blood or eyes or tissues with these ‘banks’ when a patient needs it. Baby Rishi could grow up and use his successfully banked cord blood cells that are considered blueprints to regenerate almost any kind of tissue to battle a disease he or his parents may have.
Close on their heels are the public and private registries that have ambitious targets and enormous resources. Registries are bio-catalogues of blood and tissue samples collected through donors and other sources (for instance, discarded placentas, embryos, umbilical cords), which would then be available for un-related patients needing a transplant. Public repositories are open to everybody and may charge a nominal to sizeable fee.
As commercial applications of medical biotechnology gather momentum, there has been a proliferation of tissue and cord blood banks in India signifying the latest wave of research tumbling out of petri dishes and into cryogenic vaults and hospital inventories.
|An indicative list of tissue banks/
repositories currently in the country:
• Tata Medical Hospital Tissue Bank, Mumbai — banks bones, skin, tissue
• LifeCell, Chennai (collection and marketing centres in 16 other cities) — private cord blood bank
• Reliance Life Sciences, Rabale, Thane, Maharashtra — cord blood repository (bank)
• Jodhpur Defence Laboratory, Jodhpur — tissue bank.
Commercial applications are finding new traction almost as quickly as research breaches medical barriers. For instance, cord blood cells are adult stem cells (unlike stem cells collected from embryos, which have attendant medico-legal-ethical issues on the question of embryos being considered life forms by some religions and their destruction is therefore controversial) and are viewed by many scientists to be an ideal source for new master cells used for tissue replacement and other treatments. The master cells can regenerate important tissue like blood, liver, heart and so on. Other tissues being banked include bones and amniotic membranes (placenta linings).
LifeCell has a technology tie-up with Cryo-Cell International (CCI) USA, and is promoted by the South-based Sriram Group. For a fee (all-told Rs 59,000 or instalment-based) it banks the cord blood of newborn babies in liquefied nitrogen for 30 years, after which the deposit term can be renewed. From birth to death, should the person require a transplant at any stage, a bank of his or her own tissue will, hypothetically, be available.
LifeCell is soon going to find competition at its eastern outpost. Around mid-2007, the Singapore-based CyGenics in collaboration with Strassenberg, Calcutta, will open its tissue and cord blood bank at Diamond Harbour on the eastern flank of the city.
CyGenics’ self-professed state-of-the-art tissue processing and storage facility will have a capacity of over 40,000 units of cord blood units and provision for extending the storage capacity. CyGenics has already tied up with several hospitals and obstetricians, including an “exclusive market awareness and public education collaboration” with Woodlands Medical Centre, Calcutta. And, like LifeCell, CyGenics too will look to extend its footprint in other cities.
LifeCell is opening a transplant hospital on the heels of its cord blood bank, and will also start a public bank for hospitals. Public banks cater to non-donors for a fee or usually lower prices.
Some of these commercial options are in the public domain sometimes in advance of established practical utility. Cord blood banks are a case in point. LifeCell lists certain kinds of acute leukemia, thalassemia and Hodgkin’s disease that are being treated with stemcells while trials are underway for diabetes, Parkinson’s and spinal cord injury. It also lists Alzheimer’s and lupus as future stem cell applications (illnesses for which stem cells may find applications in the future).
When a private company launched cord blood banking in New Delhi more than a year ago, it named more than 20 diseases as conditions for which stem cells may have applications. But doctors point out that for not a single one of those diseases has cord blood-based therapy emerged as the primary line of treatment — the first choice of therapy — today.
However, Mumbai-based plastic surgeon Kalpesh Gajiwala is highly appreciative of the breakthrough therapy from ‘refuse’ such as placenta and umbilical cord. “You cannot make what nature makes,” he says. For instance, the inner membrane of the placenta is used to make amnion, a paper-thin non-adhesive biological dressing that can be applied on uneven contours and is less painful then a conventional dressing, and allows tissue to regenerate more efficiently.
Amnion dressings are developed at the TMHTB. Umbilical cord blood yields stem cells that have wide existing and potential curative and regenerative use. Tata’s tissue bank supplies about 1000-1500 graphs (stored for a year) to patients and hospitals, says A.L. Gajiwala, head of the tissue bank.
A private biotech company dismisses companies such as Lifecell and CyGenics as “contributing to hocus-pocus and taking parents for a ride” but admits that it will soon be following suit and start its own cord blood bank.
The huge population of the state which provides a potentially large range of matching samples is one of the reasons that led CyGenics to set up shop here. Meghnath Roychoudhury, vice-president, marketing, thinks more players will result in healthy competition in this industry. Families will have options in terms of costs and facilities. Companies too hope to find not just clients, but a host of donors as well.
Reliance Life Sciences (RLS) has a stem cell cord blood repository with over 3,500 samples, collected through tissues and cord blood given by donors, hospitals and discarded material. Someone looking for an organ or tissue transplant can check for an available match after a profiling analysis called Human Leukocyte Antigen (HLA) typing — of six genetic markers, between three and five (average to good) should match — for it to work.
The cost of processing the transplant material (to see if the collected blood is disease free and analyse it for genetic markers) can run up to Rs 2 lakh.
“For RLS, tissue and cord blood banking go far beyond ‘banking’ to creating a public repository where one would be able to find transplant material for several unmet patient needs,” says RLS president and CEO K.V. Subramaniam. “While RLS does provide stem cell enriched cord blood banking facilities, we are committed to building the world’s largest repository.” Currently, it collects discarded or voluntary donations of organs and tissues from hospitals.
Clearly, medical biotech companies and hospitals around the world are in a race to build up repositories for patients looking for organ and tissue transplants.
This is mainly because one cord blood collection is used only for one transplant. Doctors even prefer to do so as it optimises the patient’s chances of survival. The current world standards also call for storage as a single integrated unit.
Interestingly, in this burgeoning industry, the regulatory hawk has trailed behind the lab rat. Currently, the Transplantation of Human Organs Act, 1994, governs procurement of tissues for transplantation. Rules and regulations that are specific to tissue banking have yet to be developed, points out A.L. Gajiwala. “This is one of the biggest challenges facing the industry.”
And yet, there is no comprehensive regulatory framework for this industry. A.L. Gajiwala expresses concern at a potential lack of peer validation of research, inadequate donor/patient education, ethical safeguards and an updated law that governs the commercial application of medical biotechnology products, services and its therapeutic uses.
In the meantime, several public and private enterprises are setting up shop here governed loosely under a clutch of existing regulations such as the Transplantation of Human Organs Act. But, crucially, as A.L. Gajiwala points out, there is “no cohesive regulatory authority” for such tissue and cord blood banks. There is an urgent need for standardisation of norms for tissue collection, blood screening, quality control, patient and donor safeguards and information rights.
RLS is satisfied with the present regulatory environment as conducive to research geared towards commercial applications.
But most players are consolidating and in some cases, expanding. TMHTB is working on setting up a national training programme to set up tissue banks by government hospitals. In Maharashtra, the directorate of health services will be setting up a public tissue bank with the TMHTB’s guidance as did the Defence Laboratory, Jodhpur. The TMHTB is a non-profit facility that provides a range of human allografts (including amnion, skin and bone).
Public tissue and cord banks are being initiated through private-public partnerships such as between Tata and the Maharashtra government. LifeCell will also start a public bank in collaboration with hospitals in January. CyGenics plans to follow while RLS will take its repository online.
In Next, Michael Crichton plots his intensively researched latest bestseller in America against the backdrop of genetics. In his appended notes, Crichton argues that the US government should establish clear guidelines for the use of human tissue and that patients should have control over their tissue donations.
Nearer home, writing in Current Science last year, Saionton Basu, practising advocate in the Supreme Court, emphasised the need for a permanent regulatory body, which would monitor all aspects of stem cell research in India, ranging from “the power to license centres involved in stem cell research (and) projects on stem cell research and embryo storage” to providing advice and information to the public, prospective patients and clinics without hampering research.
But Shobhana is not unduly perturbed by the ongoing debate. “Instead of looking for a donor, if my child should ever require he can use his own cells. I think the one-time fee is a small price to pay in anticipation of new medical breakthroughs through the rest of his life,” says Shobhana.
By the time he turns 18, Rishi will become the formal custodian of what by then may not be such an unusual account.