LifeLine in Deep Freeze

The knowledge that placenta blood is rich in stem cells (see box) is three decades old. If it took India so long to act on it, the second step — placenta on call, if at a price — has come super quick.

Fast forward to November 2003. In the silent hours before dawn, a woman delivers a healthy baby in a Delhi hospital. By 8.45 am, an unusual DHL parcel lands at a sophisticated, little-known research centre in South Mumbai. Inside, a group of scientists swiftly and gently unpack the pouch to reveal a potential gift of life that midwives and hospitals snip and dump as waste, seconds after birth.

It is 60 ml of umbilical cord blood that will survive, frozen and undisturbed in stainless steel canisters, an ageless ‘‘safe product’’, even when the baby graduates from college. Scientists at the $5 million Reliance Life Sciences (RLS) cell biology research centre have an affectionate nickname for the new arrival: biological insurance.

In just over a year since Hemant was operated on, medical technology promises to rewrite the story of cord blood transplants in the country. ‘‘The transplant of placental blood is a useful technique in cases of children with blood disorders, especially paediatric thalassaemia and leukemia,’’ says Lt-Col Rajat Kumar, professor, department of haematology at AIIMS, and the doctor who operated on Hemant.

While cord blood storage has been available in major hospitals across India for some time — Hemant’s brother’s placenta, for instance, was stored in the Army Hospital for one-and-half years — the RLS facility is the first to operate on a commercial basis, launching a Sibling Donor Programme that allows a mother to bank her newborn’s placenta for the use of an elder child or family member. In a country with 30 million to 40 million carriers and 6,000 to 8,000 thalassaemia major births every year, it is big news.

‘‘So long, we concentrated on building the facility. Now we would like to bring the benefits to the clinical domain in a graduated manner,’’ K V Subramaniam, CEO, Reliance Life Sciences, told The Sunday Express.

Despite the low profile it has studiously maintained, RLS has been fielding phone calls and e-mails from families across the country. ‘‘Queries for cord blood storage are coming not just from Delhi, Mumbai, Bangalore but also from Hyderabad, Indore, even Gadchiroli in Maharashtra,’’ says a scientist requesting anonymity.

The presence of hematopoietic stem cells in umbilical cord blood was first reported in 1974. Subsequent laboratory studies suggested that cord blood could be tapped for stem cells for transplants in blood-related diseases like leukemia and thalassaemia. The first successful transplant was performed in 1988 in France on a child with Fanconi’s anaemia, while the first transplant for leukemia was reported in 1992.

AT select nursing homes across the country, RLS-trained staff politely ask for permission to address meetings of moms-to-be and project slide shows as dumbed down as what-is-a-placenta. ‘‘At group meetings, many women agree to donate cord blood to RLS instead of wasting it. Such cord blood can be collected and stored and given to any recipient if the parameters match,’’ explains a scientist.

But in Tamil Nadu, a pregnant woman with a leukemic five-year-old is taking no chances. She goes through a tedious informed consent form (available in English, Hindi, Marathi and Gujarati) and signs up to send cord blood for storage to RLS immediately after the birth of her second child.

A collection kit is flown down from Mumbai even as she juggles accounts, unsure if she can fork out Rs 80,000-odd for 12 months. But if it gave her older boy a second chance, why not?

Since cord blood immune cells are less mature than those in the bone marrow — the other known source of stem cells — siblings are twice as likely to be able to use each other’s cord blood as bone-marrow. International studies peg chances of a cord blood match outside the family at around 1 in 1 million.

Even with the high odds, there’s a catch. Thalassaemics, whose red blood cells are incapable of carrying oxygen, can only receive transplants from related donors. Leukemics — not a large number in India, accounting for about 2 per cent of total cancers in the country — are slightly more liberal.

But for Reliance, who plan to pump in $25 million into the centre over the next few years, the figures don’t matter. ‘‘The stem cell-rich cord blood repository is an investment we are making for the future in order to be able to bring about an era of regenerative medicine,’’ Mukesh Ambani, chairman, Reliance Industries Limited, told The Sunday Express.

So far, RLS has preserved nearly 1,720 samples of cord blood (named ReliCord), to be made available to potential recipients. Each sample in the bioarchive is manoeuvred by a computer-controlled robotic arm and periodically checked for cell viability. Theoretically, researchers say, cord blood can last 21 years, may be even a lifetime.

SINCE RLS was incorporated in 2001, the cell biology research centre has focused on stem cells and tissue engineering. RLS has trained some 20 doctors nationwide to inform their patients about cord blood storage, direct queries to Mumbai and collect samples by specified methods.

Once in Mumbai, the cord blood sample gets a mighty fuss-over and a unique barcode identity. It is processed to settle into a frozen existence after screening for active and latent infectious diseases including HIV (I and II), Hepatitis B virus, Hepatitis C virus, and HLA typing, all of which information is maintained in a database.

HLA matching refers to proteins called Human Leukocyte Antigens (HLA) that appear on the surface of white blood cells and tissues. While RLS scientists determine tissue compatibility between a patient and a donor on the basis of six HLA points or loci — a 6/6 match being perfect, and a 3/6 match acceptable — Dr N K Mehra, head of the Department of Transplant Immunology and Immunogenetics at AIIMS, says at least eight out of 10 loci have to match in a cord blood transplant, the same as in bone marrow.

While more than 2,000 cord blood transplants have been performed across the world so far, in India, only 10-15 ‘related’ cord blood transplants have been done at Tata Memorial Hospital, Mumbai; AIIMS, New Delhi; Apollo Cancer Hospital, Chennai; Army Hospital (R&R), New Delhi, and a few centres in Kolkata. However, not many of these operations have been successful.

Perhaps because of this, doctors here are ambivalent about the idea of cord blood storage. ‘‘More stem cells can be collected from the bone marrow than the placenta,’’ says Dr Shyam Aggarwal, head of the department of oncology at Sir Ganga Ram Hospital, New Delhi.

Moreover, in comparison to bone marrow and peripheral stem cell transplants, cord blood transplants are more time-consuming; the risk factor is also higher. ‘‘The time taken for engraftment is much longer in cord blood transplantation. Also, as the bone marrow count is reduced to zero, the patient’s immunity drops to zero. So the risk of potentially fatal infections is high, as also the mortality rate,’’ says Dr Kumar.

Doctors also emphasise that cord blood, by itself, cannot help a child above the age of three regenerate blood cells. ‘‘A critical number of cells is required for the bone marrow to regenerate. A single placenta gives about 60-100 ml of blood, and it is not sufficient for a child above a certain age,’’ says Dr Amita Mahajan, consultant paediatric oncologist at Indraprastha Apollo, New Delhi. ‘‘After that, it has to be supplemented by matching cord blood specimens or donated bone marrow.’’

So a cord blood bank would at least come in handy when shopping for matching specimens, right? Doctors aren’t too sure, as the efficacy of the transplant falls with the number of placentas pooled. ‘‘As things stand today, the option seems to be to go in for storage only if a family has a child suffering from a blood disorder, particularly thalassaemia, of which there is a high incidence in India,’’ says Dr Mahajan.

For affected families who can afford it, though, doctors acknowledge that storage facilities offer many advantages. ‘‘The banks can provide HLA-matched stem cells on demand. Plus frozen cord blood can be conveniently tapped, unlike freshly donated marrow, which has a limited shelf life and calls for coordination between harvesting and transplantation teams,’’ says Dr Kumar.

‘‘Each cord blood stem cell can form more blood cells than a stem cell from adult blood,’’ Dr Aggarwal adds to the positives. ‘‘Plus, cord blood is also relatively free of viruses. Many viruses that can be transmitted through bone marrow or blood do not cross over from the mother’s circulation to the placental and fetal circulation.’’ The fallout: lower risk of the donor cells attacking the patient’s tissues.

GOOD enough for Pune — western India’s growing biotech hub — which is drawing up plans to offer cord blood storage to mothers nationwide. ‘‘We were seriously planning collaboration with a company in Denmark, but it went bust six months ago. Now we are negotiating with a German collaborator,’’ cardiologist Dr Purvez Grant, trustee, Ruby Hall Clinic, told The Sunday Express from Pune. ‘‘Our facility will collect samples from all over India and store them at Ruby Hall Clinic.’’

Even adults are banking on stem cells. Last month, RLS received a sample from a Gujarat cancer patient who had been declared ‘‘clinically treated’’. In his mid-30s, he decided to take no chances, but shrewdly bank on his luck. He sent RLS a set of stem cells extracted from peripheral blood. In case there is a tragic relapse two or three years hence, the cancer survivor will withdraw his biological life savings that doctors can infuse back in his system. The stem cells will get busy on the job, soon multiplying to restore his immunity levels.

And a second chance for a normal life.