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Drugs of interest to pathologists

Drugs related to clinical pathology

Hematopoietic progenitor cells - cord blood


Author: Him G. Kwee, M.D. (see Reviewers/Authors page)
Revised: 19 January 2012, last major update January 2012
Copyright: (c) 2012, PathologyOutlines.com, Inc.

General
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● Allogeneic hematopoietic progenitor cells derived from cord blood (HPC-C)

Trade name
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● HemaCord®

Clinical information
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● Approved by US Food and Drug Administration on November 10, 2011 for 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
● The risk benefit assessment for an individual patient depends on the patient characteristics, including disease stage, risk factors and specific manifestations of the disease, on characteristics of the graft and on other available treatments or types of hematopoietic progenitor cells (HemaCord, New York Blood Center, Inc., full prescribing information)
● The FDA found evidence of effectiveness of HemaCord for improving survival in hematological malignancies and severe combined immunodeficiencies
● However, the FDA did not find substantial evidence of effectiveness for improving survival in Hurler syndrome, Krabbe disease, X-linked adrenal leukodystrophy, primary immunodeficiencies, bone marrow failure and beta thalassemia, US Food and Drug Administration, Review Memo, November 10, 2011, HemaCord)

Drug administration
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● Each unit of HemaCord contains a minimum of 500 million total nucleated cells with a minimum of 1.25 million viable CD34+ cells, suspended in 10% dimethyl sulfoxide (DMSO) and 1% Dextran 40 at the time of cryopreservation
● The active ingredients are the hematopoietic progenitor cells, which express the cell surface marker CD34
● The inactive ingredients are DMSO, Dextran40 and human serum albumin
● The potency is determined by measuring the numbers of total nucleated cells and CD34+ cells and cell viability
● The actual nucleated cell count, the CD34+ cell count, the ABO group and the HLA typing are listed on the container label
● Matching for at least 4 of 6 HLA-A antigens, HLA-B antigens and HLA-DRB1 alleles is recommended
● HemaCord should not be irradiated
● HemaCord should be stored at or below -150 degrees Celsius until ready for thawing and preparation
● Once prepared for infusion, HemaCord may be stored at 4-25 degrees Celsius for up to 4 hours if DMSO is not removed, and at 4 degrees Celsius for up to 24 hours if DMSO is removed in a washing procedure
● If more than 4 hours elapse between thawing and infusion, an aliquot of the product should be removed and tested immediately before administration to the patient to determine the cell viability of the product
● The recommended limit on DMSO administration is 1 gram per kg body weight per day
● HemaCord cannot be administered in the same tubing concurrently with other fluids other than 0.9% Sodium Chloride, Injection (USP)
● HemaCord may be filtered through a 170 to 260 micron filter designed to remove clots, but not through a filter designed to remove leukocytes

Side effects / treatment failure
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● Adverse reactions include infusion reactions, graft-versus-host disease, engraftment syndrome, graft failure, malignancies of donor origin such as post-transplant lymphoproliferative disorder and leukemia, transmision of infections and transmission of rare genetic diseases (JAMA 2011;306:2442)
● Primary graft failure is defined as failure to achieve an absolute neutrophil count greater than 500/uL by day 42 after transplantation; the primary cause of graft failure is immunologic rejection
● Testing for HLA antibodies should be considered to identify patients who are alloimmunized prior to transplantation and to choose a unit with a suitable HLA type
● HemaCord contains lysed erythrocytes that may cause renal failure
● Monitoring of urine output is recommended (HemaCord, New York Blood Center, Inc., full prescribing information)

Donor screening
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● Donors are screened for HIV, HBV, HCV, HTLV, T.pallidum, T.cruzi, West Nile virus, transmissible spongiform encephalopathy agents, vaccinia, clinical evidence of sepsis and communicable disease risks associated with xenotranplantation
● Testing for CMV is also performed, but this is not a donor selection criterion; the test result is shown on the container label
● Cord blood donors have been screened by family history to exclude inherited disorders of blood and marrow
● Donors with sickle cell anemia and hemoglobinopathies C, D and E are excluded by testing

End of Drugs > Drugs related to clinical pathology > Hematopoietic progenitor cells - cord blood


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