U.S. Health Agency Seeks Advice
on National Cord Blood Program

An approach for a national cord blood stem cell bank program has been announced by the Health Resources and Services Administration (HRSA), accompanied by a request for public comment and recommendations.

The government’s announced plan would establish:

• a “National Cord Blood Coordinating Center” to administer the program under contract to HRSA
• a network of cord blood banks qualified to participate in the program by meeting minimum banking and laboratory processing standards, verified through inspection and accreditation
• an advisory board to guide HRSA on all aspects of the national program

The request for comments was issued Aug. 15, and the deadline is Sept. 12.

Congress proposed the creation of a national cord blood stem cell bank program and allocated an initial $10 million to establish the program.  The purpose is to “build an inventory of the highest quality cord blood units for transplantation and ensure an integrated system through which physicians and patients are able to locate a suitably matched cord blood unit or adult volunteer marrow donor via a single, electronic access point.”

The objects of the national cord blood program, as stated by HRSA, will be “high quality cord blood units, a single point of access for patients/physicians to all sources of blood stem cells, and complete and accurate data on the outcomes of transplants.”

A portion of the units is to be available for pre-clinical and clinical research.

FDA regulations governing processing human tissues including cord blood went into effect this past May.  The FDA does not yet license cord blood banks or cord blood units, but has announced an intention to develop a standards-based approach to licensing human tissues including cord blood.   Most cord blood banks have been operating under investigational new drug (IND) applications. 

HRSA says that it will solicit competitive proposals from organizations capable of performing coordination, banking, standards development and accreditation within the national cord blood program and expects to award contracts in early 2006.