Cord Blood Bank Rules and Regulations

A cord blood bank stores umbilical cord blood at its facility for future use. In response to the potential medical use of cord blood transplants to treat diseases of the immune and blood system a significant number of both public and private cord banks were built during the last decade of the twentieth century.

Although private cord blood banks are available it generally isn’t recommended that cord blood be stored in a private bank in most instances.

A public cord bank will accept cord blood donations that can be used by anyone who needs it. The medical community supports public cord banks.

Nonetheless, public cord banks need to follow strict regulations if they want to have their donated units added to a registry.

For the most part expectant mothers should get in touch with a public bank prior to her thirty fourth week of pregnancy if she would like to donate her newborn’s cord blood to the bank. If you are interested you can find a list of public cord banks on the Internet of the National Marrow Donor Program website.

After the cord blood has been donated to a public storage facility any identification information is lost once the initial testing period has transpired. Therefore, families cannot retrieve their own cord blood once it’s been donated.

However, it is quite unlikely that a family would need to use their own sample in most cases.

Currently family banks or private cord banks are subject to state and FDA regulations. Private cord banks should also apply to be accredited by the AABB. This association requires that the cord blood banks are subject to a bi-annual audit. This will ensure that the accredited banks are following the AABB’s quality assurance guidelines.

The majority of private cord banks charge an initial fee of between one thousand and two thousand dollars to preserve the harvested stem cells. People often look at it as a type of biological insurance.

Currently cord blood is being used as a treatment for blood and immune system related genetic diseases as well as blood disorders and different types of cancer.

The first time that the use of cord blood stem cells were clinically documented was in 1988 when they were used to successfully treat a 6 year old boy who was afflicted with Fanconi anemia. From that point on umbilical cord blood has become recognized as a primary source of stem cells that could be used for various types of stem cell therapy.

It’s been found recently that cord blood has several unique advantages when compared to traditional bone marrow transplantation. This is especially true for children.

In many instances it can be life-saving because a suitable donor can’t be found within a critical time frame.

Approximately half of all the patients that need a bone marrow transplant aren’t able to find a suitable donor. The vast majority of donors are unrelated to the patients that require the transplants.

Be it a private cord blood bank or a public bank, the main concern is whether the cryogenically frozen cord blood will remain viable for the long term. Studies have indicated that properly prepared and stored cord blood may be cryogenically frozen for an indefinite period.

The collection, storage, packaging, labeling and distribution of cord blood stem cells is governed by the FDA. Two different standards could apply – current Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP).

The Center for Biologics Evaluation Research regulates the standards for the collection, storage and processing of human cells, cellular/tissue based products and tissues.

Every cord blood bank in the United States must be in compliance with cGTP standards.

If a product is manufactured and considered to be a drug then cGMP standards apply.

Whether a cord blood bank needs to be compliant with cGMP standards is based on the product(s) that they manufacture.

For example, the manufactured cord blood stem cells are overly manipulated or if the cells are used for people that are first or second degree blood relatives, or if the cells will be used for the same basic biologic function, then the product only will be regulated under cGTPs.

However, there are a lot of similarities between the two because cGTP standards are based on cGMP standards.

About The Author: Robert O. Dewald has written this article.