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AABB advice to Parents in India

Březen 2015
Association for the Advancement of Blood and Biotherapies (AABB)

 

India family cord blood banks map

Stem cell transplantation has come of age. Over 80 diseases can now be treated with stem cell transplants, and clinical trials with stem cells are in progress to provide additional therapies in the future.

Those companies that provide stem cell banking with high quality and true ethics will only promote stem cell therapies that are based on scientific facts. Too many private cord blood banks are taking a more emotive approach, making false claims, and using eye-catching features to attract clients.

In India, accurate education is needed at all levels for all participants in the banking process. Classes should be conducted for doctors and gynaecologists in all cities and towns of the country and neighbouring nations. Regular counseling sessions should be conducted by doctors and counselors to explain the stem cell concept to pregnant patients in hospitals, clinics, and nursing homes.

The Indian Council of Medical Research (ICMR) and Drugs Controller General of India (DCGI) have set standards for all cord blood banks. Cord blood banks of good repute will not only follow these standards, but will also have a track record of experience, and will have attained global accreditation by meeting standards such as those of AABB and/or FACT.

Here is what parents who are contemplating cord blood banking should know:

Information: Parents should be given all available information regarding stem cell medicine. All queries from the public should be answered by knowledgeable experts. For those cord blood banks accredited by AABB, a technical specialist is available to answer all inquiries submitted to the Accreditation mailbox.

Collection: The cord blood collection should be performed by trained nursing or paramedical staff. This helps to ensure good volume, no clots, and no contamination. Well trained nursing staff can improve the size of the collection, and the simple fact is that more volume means more stem cells.

Materials Used: Collection bags, cryogenic storage bags, chemicals used in processing, etc. must all be from reputed suppliers to ensure global quality standards. The accreditation organization AABB requires that materials used in processing should either be approved for human use by the Food and Drug Administration (FDA) of the United States, or by the relevant competent authority when possible, or should have medical literature to support their use.

Transportation of Collection Kits: After the cord blood is collected, government regulations require that it must be transported to the laboratory within 72 hours, while maintaining temperature in the transport kit below 25 degrees Celsius.

Processing and Storage: The technology used to reduce the blood volume and/or separate stem cells should be up to the quality of international standards so as to maximize stem cell yield and minimize microbial contamination.

Storage Location: A bank may choose to store the final stem cells in two portions of a bag or in two locations, to give parents peace of mind about natural or manmade calamities. Nowhere do the standards of the US FDA or India DCGI say that dual storage is not permitted. For each sample stored, the entire laboratory process has to be validated to ensure that the final product meets release specifications for viability and potency of the stem cells.

Transplant Experience: A reputed cord blood bank will have a fair number of retrievals for transplants. Cord blood samples that are released for clinical trials in countries abroad must meet the requirements for import into those countries. A bank that offers public cord blood banking must meet the international registry requirements for stem cell therapies from an unrelated donor.

This summary of important points will allow parents to take a well-informed decision, in absence of any false, misleading attractions.