Cord blood banking guidelines for India soon

India is being sought after for not only its clinical/research expertise but also as a bank of stem cell lines.

T he forthcoming stem cell policy of the Indian Council for Medical Research (ICMR) and the Department of Biotechnology (DBT) will also contain guidelines on umbilical cord blood banking facilities. This is in response to the increasing demand for setting umbilical cord blood banks in India. The cord blood cells can be harvested to cure a gamut of malignancies like leukaemia, Hodgkin's disease, different types of anaemia and inherited metabolic disorders.

The guidelines will be drafted in consultation with Chennai-based Asia Cryo Cell Private Ltd, whose Lifecell, a joint venture between Asia Cryo Cell and Florida based Cryo-Cell International (CCI), is deemed as the first private stem cell bank in India, and Mumbai-based Reliance Life Sciences. The government had approached both the private bodies for their suggestions some time back. The cord blood banking guidelines would be of international standards and would have specifications for requirements like space, equipment, lab expertise, approval from patient and protocol.

India is viewed as an attractive cord blood banking destination because of its largest birth count in the world and its one-billion plus population is genetically diverse enough to match the genetic characteristics of people worldwide. The cord blood is a rich source of stem cells which having the potential to cure serious ailments. The cord stem cell banks process leftover umbilical cord blood from the placenta and umbilical cord after the baby is delivered, and preserves by freezing them in liquid nitrogen at a temperature of -195 degrees celsius. Umbilical cord blood banks can be divided into two categories: private and public. In private banks, one can keep the umbilical cord for two decades, which can be claimed by the family or the patient.

Realizing its vast potential, both the public and private groups have been looking at this area with interest. The first cord blood repository in India was established by Reliance Life Sciences (RLS). The company is in the process of setting up its Cord Blood Repository (CBR) and plans to grow the repository to around 30,000 units over the next two-three years. The CBR is part of the cell biology group and has to date, collected, tested and stored the cord blood. RLS is expected to complete the HLA (Human Leukocyte Antigen) typing of the blood in the coming future, which would be followed by animal testing and matching of donor-receiver. The company is then aiming at scaling up its operations - the critical mass being 10,000 stem cell units before the company can join a global network of cord blood repositories.

The first strictly private cord blood bank in India is Asia Cryo-Cell Pvt Ltd (ACCPL), an affiliate of the American bank Cryo-Cell International based in Chennai, which began operations in late 2004.

In addition, cord blood and bone marrow transplantation has been carried out at leading Indian medical centers for the last 20 years: All India Institute of Medical Sciences (AIIMS), New Delhi; KEM Hospital, Mumbai; Christian Medical College (CMC), Vellore and Indian Institute of Haematology, Mumbai, although these still do not have a dedicated cord blood centre or bank. Recently the Apollo Group of Hospitals has signed a memorandum of understanding (MoU) with the blood bank Histostem Inc to offer stem cell therapy to patients from South Asia. As part of the deal, Histostem India will train doctors and nurses at Apollo for stem cell treatment protocols and develop new treatment protocols with relevant regulatory approval.

Meanwhile, a government-sponsored program of public banks was announced in July 2005. The Maharashtra government signed a deal with Histostem to set up a national cord blood bank in Mumbai, with additional centres planned for Delhi, Chennai and Kolkata. The company will be investing close to $20 million to create the facility. Ultimately, these centres will offer regenerative stem cell therapies for spinal cord injuries, brain strokes, diabetes and bone cancer.

Looking at increasing number and activity of players in the cord blood banking arena, it is essential to spell out the guidelines clearly for this niche segment.

Rolly Dureha

Dr Hwang: In the eye of a storm

Stem cell controversy tempers hope of patients and researchers

Fraudulent research claims have effaced the fledgling stem cell arena

After a month of controversy, claims and counter claims it has now been conclusively established that Prof Hwang Woo Suk's work on cloned human embryos and stem cells was fabricated.

Seoul National University's (SNU) investigative panel confirmed that Hwang had fabricated data in the article published in Science last year in which he claimed to have produced 11 stem cell lines genetically tailored to patients. The panel has also reported that the scientist's landmark claim of cloning a human embryo and extracting stem cells from it was also a fake.

When this study was published in Journal Science in 2004 it was hailed as a path breaking achievement and brought Hwang instant limelight. Now the SNU investigative panel report has stated that there was a high possibility it could have merely been a mutated egg, which could appear to have similar qualities of an embryo.

In its final report, the university investigating panel said that Hwang and his research team "did not have any proof to show that cloned embryonic stem cells were ever created."

These revelations have stunned the entire scientific community and are a big setback to the research efforts in the stem cell arena. Commenting on this development, Dr K Vijay Raghavan, director of Bangalore-based National Centre for Biological studies (NCBS), one of India's leading basic sciences research centre, which is also involved in stem cell research, said, "The Korean fraud is a major setback for research-not only for stem cells, but research of all kinds. Research in emerging areas is always difficult and any success is welcomed as path breaking and as something to emulate. Thus several groups worldwide were inspired by the Korean experiments and have tried to reproduce them and have wasted valuable time and effort."

Indeed, the hopes of patients as well as researchers were buoyed by Hwang's claims but now realizing that cloned stem cells are a long way off, the euphoria created is slowing subsiding.

Prof D Balasubramanian, director - research, LV Prasad Eye Institute and chairman, Department of Biotechnology (DBT) Task Force on Stem Cell Research, said, "The work by Hwang Woo-Suk has been rightly criticized from two angles. One is the ethical aspect, where he had forced his coworker to give him her cells. Also, it is not clear how many he had taken and how many he used. Second is the reproducibility of his work. One might have read the warning statement in a recent issue of Science by Dr Ian Wilmut (the creator of Dolly) about the necessity of work of this kind to be repeated and verified independently in another lab. This was not done."

But the person in the center of the controversy, Hwang, still maintains that he has the technology to use cloning to create human embryonic stem cells genetically matched to patients and claims that he could do so in six months if he had access to enough human eggs. Hwang's claims had vaulted him on the international center stage as his studies could pave the way for future development of therapies for hard-to-cure diseases.

In fact, stem cells have the potential to mature into every cell in the human body. Scientist hope to use stem cells as replacement parts for failing organs and to treat diabetes, Parkinson's and other diseases. Researchers want to harvest stem cells by cloning the DNA of sick people, so they could turn the cells into tissue that genetically matches a patient. That way, the patient wouldn't have to take the anti-rejection drugs used in organ transplants today. Hence any research development in this arena brings a flicker of hope for
such patients.

Pointing out its impact on the scientific research especially in the Asian region, Prof K Kannan, founder dean, School of Biotechnology, Guru Gobind Singh Indraprastha University, New Delhi, said, "The biggest fallout of this entire episode is the belief that Asian science is going down. This is a big damage to the credibility of scientific research in the Asian region, especially now, when research in this region is actually picking up. This is a sad episode of cheating in the history of science. Now the regulations for accepting research results will be further tightened."

But the question remains why did a senior scientist to perpetuate such a big fraud? Did he see this as an easy chance to get fame in a nascent upcoming arena? Where his work would be one of its kind and difficult to validate? Probably! "The scientific community, including the journal needs to share some of this blame, since on a fast-moving topic, with great clinical promise, the need to be the first to publish, and the need to be the first journal to publish the work had become more pressing than scientific rigour and upholding standards of ethics", said Dr Balasubramanian.

The Journal Science has since stated that it will formally retract Hwang's two studies and is now considering how to improve safeguards against scientific fraud.

"Frauds in any area are a setback to science. In this case it points to the fact, once again, that no matter how fashionable an area one should not be trapped by the pressures of this fashion. There is no moving away from careful and honest science", opined Prof Vijay Raghavan. "Actually there is a lot of hype created around stem cells and it is being touted as a panacea for all diseases, which is not correct", added Prof Kannan.

And what will be the impact of one of the biggest scientific frauds of the century on the future of stem cell research? Not much in the long run, say experts. "In the long run this incident will not have a mark and is a temporary passing phase. This is an isolated case, generally scientists do follow ethical guidelines and claim only for what they have solid proof", said Dr Ashok Mukhopadhyay, a senior scientist working in the stem cell arena at the National Institute of Immunology (NII).

"I do not think this would affect the progress of embryonic stem cell research per se, though it will slow it down a bit, and certainly sober up all scientists and journal editors. How does this affect the suffering patients? This is a sad question, since the hope built up by Hwang and by the South Korean research agencies will now be tempered, and patients will have to wait longer. This may be actually for the good, in one sense", commented Dr Balasubramanian.

Rolly Dureha