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India is emerging as one of
the leading centres for cord blood banks, which can provide stem cells for
regenerative medicine. These are essentially blood banks, which collect, process
and store umbilical cord blood for transplants. Umbilical cord blood is blood
from the placenta and is rich in stem cells. Cord blood is collected after the
umbilical cord has been detached from the newborn, and utilised as a source of
stem cells for transplantation. Umbilical cord blood is playing an increasingly
important role in the treatment of leukemia and other life-threatening diseases.
More easily accessed than embryonic stem cells and more flexible than adult stem
cells, the stem cells recovered from the blood in the umbilical cord provide a
non-controversial treatment option for a range of diseases.
India opened its first cord
blood bank in Chennai in 2004, with a drive to collect and store umbilical cord
blood in a private bank. Twelve pregnant women registered with the private bank
called Life Cell to store their baby’s umbilical cord blood. LifeCell guarantees
that the stem cells gained from the cord blood will be stored for 21 years at a
cost ranging from Rs 30,000 to Rs 60,000. Since then, several other cord blood
banks have come up in India, many with international collaboration, all with
similar price tags. Large private banks like Life Cell, TIFR (Tata Institute of
Fundamental Research) and Cryostem Karnataka Pvt Ltd are entering the
international market and will bid for international funds to conduct research on
embryonal stem cells. All three are recognised by the National Institute of
Health (NIH) in the US, which paves the way for their international operations.
India is seen a desirable
destination for setting up cord blood banks because of its large, young
population of ethnically and genetically diverse potential donors. The use of
stem cell therapy in a number of life threatening diseases promises to be a
money spinner in the medical sector. The cord blood storage market is currently
estimated to be about US$2 billion, with every prospect of substantial growth in
the coming years. As in all other fields of medical treatment, the question here
is also that of regulation and equitable use. So far, the only countries that
have put in place regulations for stem cell research and development, are the
US, China, Singapore, Israel, Belgium and UK.
India has prepared some
guidelines but these are not official yet. Broadly, these guidelines allow work
on cord blood, adult and embryonic stem cells but prohibit the use of adult
stem cells to create a new zygote, in other words, a new embryo. A nodal body,
the National Apex Committee for Stem Cell Research and Therapy, has been
proposed where all researchers and institutions working on stem cells will have
to register. Permission from this body will be required for all applications of
stem cells, including research. All stem cell lines that have been established,
along with the source of the original material, will also have to be registered
with the apex body. Given its potential for use and abuse, a regulatory system
governing the use of cord blood stem cells will have to be vigilant in ensuring
that not just private players but also public banks are set up for cord blood,
which can be accessed by the public.
New technologies cannot be
such that they shut out the poor because they are expensive and unaffordable.
Even with stringent regulations, there are outstanding ethical and practical
dilemmas associated with this promising but radical technology. At the simplest
level, is the question of the facilities themselves: how reliable is the
infrastructure for reliable and safe storage; what will be the accepted
methodologies of processing and transport of such materials; and, how will the
integrity of the stem cells be ensured. There is no law yet, for instance, to
govern ownership of tissues like the umbilical cord or the stem cell line
generated from the cord blood. What kind of intellectual property regime will we
allow on aterial, which belongs to individuals but has been processed by
researchers and institutions? What kind of liability laws will govern this field
if things go wrong and accidents happen? How will awareness be created among the
public about the availability of this facility, so that its use does not remain
restricted to only those who can afford private cord blood banks. Necessary
policy will need to be formulated to ensure a sufficient number of public cord
blood banks and investment must be made to ensure that the public, specially the
poor, can also bring their babies for cord blood storage in the hope of treating
future diseases.
Suman Sahai |
