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Hemacord™, umbilical cord blood-derived hematopoietic progenitor cells for hematopoietic reconstitution

HEMACORD™, HPC (Hematopoietic Progenitor Cell), Cord Blood, is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated-donor hematopoietic progenitor stem cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. In treated patients with variable hematological diseases, the probabilities of 6-month and 2-year survivals are 67.4% and 49.5%, respectively. The most common primary causes of death are relapse (40%), graft versus host disease (27%) with or without infection, and graft failure (17%). In young children with a variety of lysosomal diseases, engraftment and full donor chimerism were achieved and maintained without the use of total body irradiation. The higher the doses of CD3+ cells in HEMACORD™, the higher the incidence of graft versus host disease induced by the treatment.

CONTRAINDICATIONS: Known sensitivity to dimethyl sulfoxide (DMSO), dextran 40 or plasma proteins. Fatal infusion reactions: HEMACORD administration can result in serious, including fatal, infusion reactions. Monitor patients and discontinue HEMACORD infusion for severe reactions. Graft-vs.-host disease (GVHD): GVHD is expected after administration of HEMACORD, and may be fatal. Administration of immunosuppressive therapy may decrease the risk of GVHD. Engraftment syndrome: Engraftment syndrome may progress to multi-organ failure and death. Treat engraftment syndrome promptly with corticosteroids. Graft failure: Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery. Prior to choosing a specific unit of HEMACORD, consider testing for HLA antibodies to identify patients who are alloimmunized.
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Hemacord™, umbilical cord blood-derived hematopoietic progenitor cells for hematopoietic reconstitution