The US FDA will enforce Code of Federal Regulations (12/71) to regulate functioning of cord blood banks and companies into stem cell research by May this year and this will set the benchmark in standards around the world for the emerging technology of stem cells, according to Gerald E Mass, executive vice president, Cryo-Cell International Inc., USA.

Talking to Pharmabiz in Chennai, last week, he said the ethical issues related to collection of cord blood and embryonic stem cells were hot topics for debate during the recent US presidential elections. At present, the US has about 15 leading companies working in the area of cord blood collection and research into stem cells. Thirty cord blood banks have come up in different parts of the world, according to the available information. The US companies together account for 3 lakh units in a year. Of this, Cryo-Cell, the oldest and largest cord blood bank with a track record in the field for a decade, accounts for about 80,000 units.

The legislation will mandate cord blood banks to ensure minimum donor qualifications like test of HIV, Syphilis, Hepatitis and a host of other contagious diseases. Mandating Good Tissue Practices (GTP) related to collection and processing, transportation, specifications on quality systems, clean room environment, processing room and other quality parameters are also part of the legislation having elaborate guidelines.

Except for the New York and New Jersey health departments, which had mandated specific guidelines related to collection of cord blood as part of the regulations on blood banks, the US FDA was yet to mandate specific quality parameters. The draft of the legislation was published during October, last year, and this would be legislated during May 2005, said Gerald Mass.

It may be noted that in this context, a bill-the Cord Blood Stem Cells Act of 2005-was introduced in the US House of Representatives during the first week of February 2005 to amend the Public Health Service Act to establish a National Cord Blood Stem Cell Bank Network to prepare, store, and distribute human umbilical cord blood stem cells for the treatment of patients and to support peer-reviewed research using such cells.

Gerald Mass noted that India, a country with huge population and in the forefront of embracing the emerging technology of stem cells, could leverage this technology, thanks to its potential in offering cost-effective treatment solutions. So far about 5000 stem cell related surgeries have been taken place around the world in about 70 disease categories.

According to Dr. Sujatha Chandrasekharan, director, Processing Operations, Life Cell, Chennai which is the first Indian cord blood bank, about 25 reported stem cell surgeries have been conducted in India, so far. Of this, five were in Chennai. The quality systems and other standards including collection practices followed by LifeCell conform to the proposed US standards. A team of Indian regulatory officials audited Lifecell's Kelekottiyur facility recently, and has issued license under the category of blood banks. The regulatory officials have directed Lifecell to enter into an agreement between the donor of cord blood and the company before collecting cord blood, said Sujatha.