How transplant centers deal with the dextran shortage: recommendations for comparing alternatives.

Abstract

BackgroundIn the United States, dextran 40 in 0.9% NaCl is the preferred reagent for the thawing and preparation of cord blood units for hematopoietic stem cell transplantation. The recurring nationwide shortage of this reagent could have implications that extend to the avoidance of cord blood for transplantation.Study design and methodsTo address the shortage, the National Marrow Donor Program and its Cord Blood Advisory Group sought to identify available alternative reagents or manufacturers. A sample of transplant centers (TCs) were surveyed to determine their process to compare these alternatives. The TCs were then asked to share their comparability protocols for review.ResultsThe 12 TCs that responded to the survey studied various types of alternative reagents and manufacturers of the standard dextran 40 in 0.9% NaCl. Four TCs submitted their protocols from which a model comparability protocol was created for centers who need assistance.ConclusionWhether comparing dextran 40 in 0.9% NaCl to that of a different manufacturer or a different reagent, the results of the comparability studies submitted by the TCs indicated equivalency. During a shortage, the model comparability study protocol can be used as a reference to establish an alternative to dextran 40 in 0.9% NaCl.