Daniel Weisdorf - Comment

The uniqueness of an identified cord blood product for a specific recipient is paramount and of course, potentially life-saving. For such unique products, where few or no alternatives exist, their one-time use for a specified recipient should be acceptable, even if the specific product is non-conforming. Just as a unique sibling donor or unrelated donor stem cell containing product can be acceptable even if all elements usually required for blood product safety cannot be assured (geography, viral history etc), an identified cord blood unit can provide irreplaceable stem cells for a transplant recipient and thus life-saving opportunity for a transplant. Non-conforming units should be acceptable if unique and should not be specifically licensed nor require product specific IND. This would provide a substantially greater paperwork and administrative barrier to their use; but not provide the identified recipient any added safety. The proposed IND guidance regulation is ill-advised and should not be adopted.