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Testimony on Guidance Document for Licensing Cord Blood Banks

Testimony on Guidance Document for Licensing Cord Blood Banks. Elizabeth J. Shpall, MD Vice-President International NetCord Foundation. NetCord Officers. President: Joan Garcia, MD, PhD (Barcelona) Vice-President: Elizabeth Shpall, MD (Houston)

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Testimony on Guidance Document for Licensing Cord Blood Banks

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  1. Testimony on Guidance Document for Licensing Cord Blood Banks Elizabeth J. Shpall, MD Vice-President International NetCord Foundation

  2. NetCord Officers • President: Joan Garcia, MD, PhD (Barcelona) • Vice-President: Elizabeth Shpall, MD (Houston) • Secretary: Eliane Gluckman, MD (Paris) • Treasurer: Yves Beguin MD, PhD (Liège) • Immediate-Past President:Peter Wernet, MD, PhD (Düesseldorf)

  3. Population Growth: 2000 to 2020

  4. Worldwide Distribution of Transplant Centers in the NetCord Virtual Office 130 78 27 10 1 42 7

  5. Source of Cord Blood for U.S. Transplants • In calendar year 2005, there were 759units of cord blood shipped for transplantation in the U.S. • 84% from U.S. cord blood banks • 16% were imported • In calendar year 2006, there were 891 units of cord blood shipped for transplantation in the U.S. • 81% from U.S. cord blood banks • 19% were imported Source: World Marrow Donor Association

  6. Imports of Cord Blood are Growing • Based on the WMDA data, it is estimated that about 20% of the units of cord blood transplanted in the United States are imported. • Based on both WMDA and NMDP records, imports of cord blood are growing.

  7. Netcord Concerns • There are professionally recognized international standards developed by NetCord and FACT for collection, preservation, selection, testing and transport of cord blood. • A rigorous system of onsite inspections and accreditation has been developed, and most of our banks are either accredited or in the process of seeking accreditation.

  8. Cord Blood Transplantation • The selection of cord blood units is the practice of medicine. • U.S. patients are ethnically diverse: the best cord blood unit is often in another country. • Denying access to such units would primarily affect minority patients for whom cord blood is often the only option.

  9. Netcord Concerns • There is no reason to assume that the current inventory of cord blood is not safe or that it is not of high quality. • Patients must have access to the existing inventory of cord blood, as well as to units stored in banks that are not licensed.

  10. Netcord Suggestions Requirement of CLIA-certified laboratories for testing: • Acknowledge comparable certifications from other countries. • Re-testing prior to shipment in a CLIA-certified laboratory. • Work with NetCord to assure access of their high quality cord blood units to U.S. patients.

  11. Netcord Concerns • The risk to be prevented with licensure is undefined.  The risk of denying access to the most appropriately matched units of cord blood is clearly defined. 

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