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Banking On Indian Umbilical Cords

By Scott Carney

18 November, 2006
Wired.com

CHENNAI, INDIA -- An Indian blood bank plans to take advantage of the country's booming birth rate by opening a repository for blood taken from umbilical cords.

But critics worry that without proper oversight, the massive bank could put a price tag on umbilical cords, putting the country's millions of impoverished women and children at risk of exploitation.

Cord blood is used in the treatment of many ailments, especially blood diseases like leukemia, thalassemia and sickle cell anemia.

With 43 million births a year, India is poised to be the largest supplier of umbilical cord blood in the world.

LifeCell, based here, hopes to open a cord-blood bank in December. The bank would serve anyone in the world with access to FedEx.

Most experts agree that public cord-blood banking is a good idea. Stem cells from both cord blood and bone marrow treat many blood diseases, but cord blood is easier to obtain. Cord blood is also less likely to be rejected than bone marrow, which requires an exact match, usually from a family member. Similar to a blood bank, a cord-blood bank relies on donations to cover a broad range of immune types. The more donors, the more likely patients in need will find a match.

But in India, where female infanticide and body-organ sales are not uncommon, watchdog groups worry that a massive cord-blood bank like LifeCell's could create a dangerous demand for umbilical cords.

"The notion of worldwide registries that can supply transplant tissue to each other has obvious attractions," said Satyajit Rath, a medical activist at the National Institute of Immunology in New Delhi. "The cord-farm notion, on the other hand, is very troubling. Given the reality of poverty, it is not impossible to imagine a situation where people would have (or even abort) babies simply in order to sell umbilical cord blood."

In December, LifeCell will begin collecting thousands of umbilical cord-blood samples, and will charge a fee for withdrawal. The fee hasn't been disclosed. The service will categorize the available stem cells into a searchable database. Doctors who find matches for their patients can order an overnight shipment.

"We will be able to sell to anyone in the world," said Prasad Mangipudi, vice president of LifeCell.

The United States has seven public cord banks that charge up to $18,000 per unit -- a fee that is often paid by insurers. But in India, this is the kind of profitability that raises eyebrows.

The Indian government has been slow to impose regulations on any stem-cell research. The Indian Council of Medical Research announced last month that it would draft guidelines to govern cord banking. The draft proposal, once approved, will be quite comprehensive. The approval process, however, could take years. Until then, India is something like the Wild West.

"It is dangerous to proceed with stem-cell banking without clear government guidelines," cautioned Chandra Gulhati, editor of the Monthly Index of Medical Specialties and a leading authority on medical ethics in India. "Without them there is nothing to stop a company from harvesting stem cells from aborted fetuses."

Once the guidelines are approved, enforcement is not guaranteed. The ICMR can approve or reject applications from companies that want to establish a bank. But if a company violates the law, there is no government organization tasked with shutting them down.

Mangalpudi says LifeCell will never pay for umbilical cord blood for precisely this reason. For now, the company plans to amass cord blood through private donations. Mangalpudi says it will not offer any sort of remuneration other than the knowledge that the donation might help someone in need.

For the past two years, LifeCell has run a private cord-blood bank, which caters to 4,000 paying donors who can afford their own personal biological insurance policy. Its customers bank their own blood in case they need a stem-cell treatment one day and can't find a viable donor. In a collaboration with Florida-based CryoCell, LifeCell has aggressively expanded to 19 locations throughout India. It plans to have 31 centers up and running by 2007.

Critics of private banking say it's a waste of money because the chances are slim that a patient will ever need their own stem cells. Plus, a diverse public bank will serve everyone, including those who can't afford private banking.

The lack of regulations has already derailed one public bank in India that would have served the masses.

Last year, Histostem, a South Korean biotech company, announced it would invest $20 million in what would have been the world's largest public umbilical cord stem-cell bank. The bank would have been located outside Mumbai. But according to Yung Ke, vice president of Histostem, the lack of medical guidelines in India played a key role in the breakdown of talks between Histostem and the government of Maharastra, which the company planned to partner with.

Now that LifeCell has filled the void left by Histostem, the company says it wants to ensure the cord-blood business maintains a good reputation. It is fearful that one company that violates basic ethical principles could endanger the whole industry.

"We hope that the ICMR speeds up the approval process," says Mangipudi. "Right now we are using the guidelines issued by the Food and Drug Administration in the United States."

Wired.com © 2006 CondéNet Inc

 


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