Testimony on Guidance Document for

Licensing Cord Blood Banks

Elizabeth J. Shpall, MD

Vice-President

International NetCord Foundation

ACAAI

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)

ACAAI

Population Growth: 2000 to 2020

ACAAI

Worldwide Distribution of Transplant Centers

in the NetCord Virtual Office

78130

42

2710

7

1

ACAAI

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

ACAAI

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.

ACAAI

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.   

ACAAI

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.

ACAAI

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.

ACAAI

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.

ACAAI

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.