BOX 2-2
Stratification Variables for the COBLT Study

1.

Malignant disease (infant leukemias), total body irradiation/cytokine (TBI/Cy) conditioning regimen, high-resolution HLA match (five or six of six HLAs, ≤18 years of age

2.

Malignant disease (infant leukemias), TBI/Cy conditioning regimen, high-resolution HLA match (four of six HLAs), ≤18 years of age

3.

Malignant disease (infant leukemias), TBI/Cy conditioning regimen, high-resolution HLA match (three of six HLAs), ≤18 years of age

4.

Malignant disease (infant leukemias), TBI/Cy conditioning regimen, high-resolution HLA match (one or two of six HLAs), ≤18 years of age

5.

Severe aplastic anemia, Fanconi anemia, and other marrow failure syndromes

6a.

Inborn errors of metabolism or storage diseases

6b.

Combined immune deficiencies

6c.

Other nonmalignant diseases

7.

Malignant disease (infant leukemias) with alternative conditioning regimen (bisulfan and melphalan)

8.

Adult patients (>18 years of age)

SOURCE: COBLT (2003).

in the areas of the collecting hospitals. Informed consent was obtained before admission to the hospital for labor. However, in the event that it was not possible for the mother to provide informed consent, verbal consent or preliminary informed consent was obtained immediately before or during labor and was reaffirmed after delivery. Of the 35,799 available donors, 20,710 consented to the collection of their cord blood. After the exclusion of units with low cell counts, microbial contamination, and positive serological test results for an infectious disease, and of the units that could not be collected after consent was obtained because of a lack of collection staff, the study was able to cryopreserve 8,731 cord blood units (Cairo et al., 2004).

In 2000, NHLBI convened an ad hoc committe when it realized that the study was not going to meet its goals for collection and transplantation on schedule. The study staff was having difficulty encouraging potential transplant recipients to use what was essentially an experimental product (i.e., cord blood transplantation), and it was competing with other banks outside the study that often had more suitably matched units for the transplant patients. Participation in the COBLT study was increased to include an additional 21 U.S. transplant centers, as well as access to cord blood units banked at the New York Blood Center, NMDP-approved banks, or U.S.



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