Comprehensive banking of sibling donor cord blood for children with malignant and nonmalignant disease

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Abstract
Banking of cord blood (CB) for unrelated hematopoietic stem cell (HSC) transplantation is well established. However, directed-donor banking of CB for siblings in a current good tissue practices (cGTP) environment has not previously been investigated. Families were eligible for the present study if they were caring for a child with a disorder treatable by HSC transplantation and expecting the birth of a full sibling. We devised standard operating procedures and policies to address eligibility, donor recruitment, donor and recipient evaluation, CB collection, shipping, graft characterization, storage, and release of CB from quarantine. Many of these policies are distinctly different from those established for unrelated-donor CB banks. We enrolled 540 families from 42 states. Collections occurred at several hundred different hospitals. No family was deferred on the basis of health history or infectious disease testing, but departures from standard donor suitability criteria were documented. Disease categories for sibling recipients included malignancy, sickle cell anemia, thalassemia major, nonmalignant hematological conditions, and metabolic errors. Mean CB volume (including anticoagulant) was 103.1 mL; mean nucleated cell count was 8.9 × 108. Cell dose exceeded 1.5 × 107 nucleated cells per kilogram for 90% of banked units. Seventeen units (3.4%) have been transplanted. Sixteen of the 17 CB allograft recipients had stable engraftment of donor cells. Remote-site collection of sibling donor CB can be accomplished with a high success rate and in a cGTP-guided environment. The cellular products have been used successfully for transplantation; their number and characteristics should be adequate to support the first prospective clinical investigations of sibling CB transplantation.