Testimony on Guidance Document for Licensing Cord Blood Banks

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 759 units 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. 
•