HEMACORD® (HPC, Cord Blood) is the first FDA-licensed HPC-Cord Blood cell therapy.
HEMACORD® (HPC, Cord Blood) is indicated for use in hematopoietic stem cell
transplantation procedures in patients with disorders affecting the
hematopoietic (blood forming) system. For example, HEMACORD® (HPC, Cord Blood) has been used to treat patients with certain leukemias
and some inherited metabolic and immune system disorders.
HEMACORD® (HPC, Cord Blood) contains hematopoietic progenitor cells (HPCs) from human cord
blood. Cord blood is one of three sources of HPCs used in transplants;
the other two are bone marrow and peripheral blood. The patient’s physician will decide which graft is appropriate in each case. Once these HPCs are
infused into patients, the cells migrate to the bone marrow where they
divide and mature. When the mature cells move into the bloodstream they
may potentially restore, partially or fully, the number and function of many blood
cells, including immune function.
Approval of HEMACORD® (HPC, Cord Blood) was based on reliance on safety and effectiveness
data submitted to a public docket and data submitted in the license
application demonstrating compliance with other regulatory requirements.
HEMACORD® (HPC, Cord Blood) received the first approval of an FDA license application for
a hematopoietic progenitor cell product.
HEMACORD® (HPC, Cord Blood) has a boxed warning (see below) regarding the risks of Graft
Versus Host Disease (GVHD), engraftment syndrome, graft failure, and
infusion reactions, each of which may be fatal. Patients who receive
HEMACORD® (HPC, Cord Blood) should be monitored carefully. A risk benefit assessment, unit
selection and administration of HEMACORD® (HPC, Cord Blood) should be done under the
direction of a physician experienced in hematopoietic stem cell
Indications and Usage
For use in unrelated donor hematopoietic progenitor 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® (HPC, Cord Blood) is contraindicated in patients with known hypersensitivity
to dimethyl sulfoxide (DMSO), Dextran 40 or plasma proteins.
Important Safety Information
Warnings and Precautions
Allergic reactions may occur with infusion of HPC, Cord Blood, including HEMACORD (HPC, Cord Blood). Reactions include bronchospasm, wheezing,angioedema, pruritus and hives [see Adverse Reactions]. Serious hypersensitivity reactions, including anaphylaxis, also have been reported. These reactions may be due to dimethyl sulfoxide (DMSO), Dextran 40, or a plasma component of HEMACORD (HPC, Cord Blood).
HEMACORD (HPC, Cord Blood) may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following HEMACORD (HPC, Cord Blood) administration.
Infusion reactions are expected to occur and include nausea, vomiting,
fever, rigors or chills, flushing, dyspnea, hypoxemia, chest tightness,
hypertension, tachycardia, bradycardia, dysgeusia, hematuria, and mild
headache. Premedication with antipyretic, histamine antagonists, and
corticosteroids may reduce the incidence and intensity of infusion
Severe reactions, including respiratory distress, severe bronchospasm,
severe bradycardia with heart block or other arrhythmias, cardiac arrest,
hypotension, hemolysis, elevated liver enzymes, renal compromise,
encephalopathy, loss of consciousness, and seizure also may occur. Many of
these reactions are related to the amount of DMSO administered. Minimizing
the amount of DMSO administered may reduce the risk of such reactions,
although idiosyncratic responses may occur even at DMSO doses thought to be
tolerated. The actual amount of DMSO depends on the method of preparation
of the product for infusion. Limiting the amount of DMSO infused to no more
than 1 gm/kg/day is recommended. If infusing more than one unit of HPC,
Cord Blood on the same day, do not administer subsequent units until all
signs and symptoms of infusion reactions from the prior unit have
Infusion reactions may begin within minutes of the start of infusion of
HEMACORD® (HPC, Cord Blood), although symptoms may continue to intensify and not peak for
several hours after completion of the infusion. Monitor the patient closely
during this period. When a reaction occurs, discontinue the infusion and
institute supportive care as needed.
Acute and chronic graft-versus-host disease (GVHD) may occur in patients
who have received HEMACORD® (HPC, Cord Blood) Classic acute GVHD is manifested as fever,
rash, elevated bilirubin and liver enzymes, and diarrhea. Patients
transplanted with HEMACORD® (HPC, Cord Blood) also should receive immunosuppressive drugs to
decrease the risk of GVHD.
Engraftment syndrome is manifested as unexplained fever and rash in the
peri-engraftment period. Patients with engraftment syndrome also may have
unexplained weight gain, hypoxemia, and pulmonary infiltrates in the
absence of fluid overload or cardiac disease. If untreated, engraftment
syndrome may progress to multiorgan failure and death. Begin treatment with
corticosteroids once engraftment syndrome is recognized in order to
ameliorate the symptoms.
Primary graft failure, which may be fatal, is defined as failure to
achieve an absolute neutrophil count greater than 500/uL blood by Day 42
after transplantation. Immunologic rejection is the primary cause of graft
failure. Patients should be monitored for laboratory evidence of
hematopoietic recovery. Consider testing for HLA antibodies in order to
identify patients who are alloimmunized prior to transplantation and to
assist with choosing a unit with a suitable HLA type for the individual
Malignancies of Donor Origin
Patients who have undergone HPC, Cord Blood transplantation may develop
post-transplant lymphoproliferative disorder (PTLD), manifested as a
lymphoma-like disease favoring non nodal sites. PTLD is usually fatal if
not treated. The incidence of PTLD appears to be higher in patients who
have received antithymocyte globulin. The etiology is thought to be donor
lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring
of blood for EBV DNA may be warranted in high-risk groups. Leukemia of
donor origin also has been reported in HPC, Cord Blood recipients. The
natural history is presumed to be the same as that for de novo
Transmission of Serious Infections
Transmission of infectious disease may occur because HEMACORD® (HPC, Cord Blood) is
derived from human blood. Disease may be caused by known or unknown
infectious agents. Donors are screened for increased risk of infection with
human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV),
hepatitis B virus (HBV), hepatitis C virus (HCV), T. pallidum, T. cruzi,
West Nile Virus (WNV), transmissible spongiform encephalopathy (TSE)
agents, and vaccinia. Donors are also screened for clinical evidence of
sepsis, and communicable disease risks associated with xenotransplantation.
Maternal blood samples are tested for HIV types 1 and 2, HTLV types I and
II, HBV, HCV, T. pallidum, WNV, and T. cruzi. These measures do not totally
eliminate the risk of transmitting these or other transmissible infectious
diseases and disease agents. Report the occurrence of a transmitted
infection to the New York Blood Center at 1-866-767-NCBP
Testing is also performed for evidence of donor infection due to
cytomegalovirus (CMV); however, this is not a donor selection criterion.
The result may be found on the container label and/or in accompanying
Transmission of Rare Genetic Diseases
HEMACORD® (HPC, Cord Blood) may transmit rare genetic diseases involving the
hematopoietic system for which donor screening and/or testing has not been
performed. Cord blood donors have been screened by family history to
exclude inherited disorders of the blood and marrow. HEMACORD® (HPC, Cord Blood) has been
tested to exclude donors with sickle cell anemia, and anemias due to
abnormalities in hemoglobins C, D, and E. Because of the age of the donor
at the time HEMACORD® (HPC, Cord Blood) collection takes place, the ability to exclude rare
genetic diseases is severely limited.
Day-100 mortality from all causes was 25%. The most common
infusion-related adverse reactions (≥5%) are hypertension, vomiting,
nausea, bradycardia, and fever.