Human T-cell lymphotropic virus

Articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.  Note this is the term preferred by FDA, FACT and other accreditation organizations prefer the term cellular therapy product.

The HLA system is comprised of a series of genes grossly divided into Class I and Class II HLA.  Class I heavy chain genes are coded for at the highly polymorphic HLA-A, HLA-B and HLA-C loci and are found on the surface of nearly all human cells in association with a non-polymorphic light chain called beta-2 microglobulin.  Class II heavy and light chains are encoded at the HLA-DR, HLA-DQ, and HLA-DP loci.  HLA-DR includes polymorphic genes at DRB1, DRB3, DRB4, and DRB5 loci, while the DR-alpha chain has limited polymorphism.  HLA polymorphism may be identified by antibodies (Serologic level), by T cells (Cellular level) or at the level of DNA (Molecularly defined).  Molecular definition gives the highest level of resolution while cellular recognition may be more clinically relevant.  Antigens of the HLA system may be the target of cells causing GVHD, GVL, or graft rejection.

Any organ, organ sample or specimen obtained from a living or cadaveric human donor.

Chemical applied for the separation of leukocytes within whole blood components.  Reduces the surface tension of red blood cells causing them to stack up (Rouleaux) and sediment at a rapid rate resulting in the enrichment of leukocytes in the liquid layer.

Investigational device exemption

Immunoglobulin

Interleukin-2

The ability of an individual to mount a normal immune response to foreign antigens.

Tissue culture or testing of cells outside the individual from which they were obtained; within a receptacle, such as a test tube.

Application or testing within the living body.

ABO incompatibility such that the recipient of a graft possesses antibodies reactive to the red blood cells of the donor.  Antibodies commonly found in the plasma of individuals of a given blood type are:

Blood Type           Antibody
Group A                 Anti-B
Group B                 Anti-A
Group AB              none
Group O                 Anti-A and Anti-B

ABO incompatibility such that the donor of a graft (transfusion) has antibodies reactive against recipient red blood cells. 

Blood Type           Antibody
Group A                 Anti-B
Group B                 Anti-A
Group AB              none
Group O                 Anti-A and Anti-B

Investigational New Drug

A cellular therapy product donor who does not meet all donor screening and testing requirements related to transmission of infectious disease as defined by the U.S. Food and Drug Administration, or non-U.S. equivalent.

Antibody to:

Human Immunodeficiency Virus 1 (HIV 1)
Human Immunodeficiency Virus 2 (HIV 2)
Human T cell Leukemia Virus (HTLV)
Hepatitis C Virus (HCV)
Syphilis
WNV

Antigen from:

Human Immunodeficiency Virus (HIV Ag)
Hepatitis B Surface Antigen (Hbs Ag)
Hepatitis B Core (Hbc)
Cytomegalovirus (CMV)

DNA of:

Human Immunodeficiency Virus (NAT-HIV)
Hepatitis C Virus (NAT-HCV)

A Board or Committee established by an institution in accordance with the regulations of the United States Department of Health and Human Services, or other governmental agency where applicable, to review biomedical and behavioral research involving human subjects conducted at or supported by that institution.

Cytokine released by subpopulation of T-lymphocytes capable of stimulating itself or other T cells or Natural Killer cells to proliferate and increase functional activity.

Microscope with inverted lens mounted such that objects are viewed from the bottom of the vessel up.  In the laboratory used to score hematopoietic colony assays and T cell limiting dilution cultures.

Institutional review board