BETHESDA, MD 14 June 2013—FDA on Thursday approved the fifth cellular therapy product containing hematopoietic progenitor cells from human cord blood.
This fifth product is known by the proper name HPC, Cord Blood, and is manufactured by LifeSouth Community Blood Centers Inc.
All five products containing hematopoietic progenitor cells from human cord blood have the same indication for use: hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
The labeling (PDF) for HPC, Cord Blood recommends that patients receive an antipyretic, histamine-receptor antagonist, or corticosteroid—or any combination of those drugs—30 to 60 minutes before treatment.
Infusion-related adverse reactions to the cellular therapy product can start within minutes after an infusion starts, according to the labeling. The most common such reactions have been hypertension, vomiting, nausea, bradycardia, and fever.
Detailed instructions on the preparation of the product for i.v. infusion appear in the labeling.