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

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

3. ACAAI Population Growth: 2000 to 2020

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

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

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

7. ACAAI Netcord Concerns l There are professionally recognized international standards developed by NetCord and FACT for collection, preservation, selection, testing and transport of cord blood. l 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. ACAAI Cord Blood Transplantation l The selection of cord blood units is the practice of medicine. l U.S. patients are ethnically diverse: the best cord blood unit is often in another country. l Denying access to such units would primarily affect minority patients for whom cord blood is often the only option.

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

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

11. ACAAI Netcord Concerns l 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.