A medicinal product manufactured through physical, chemical, and/or biological manipulation, such as in vitro culture of autologous, allogeneic, or xenogeneic cells. This definition does not apply to the case where a medical doctor performs minimal manipulation that does not cause safety problems of autologous or allogeneic cells in the course of surgical operation or treatment at a medical center (simple separation, washing, freezing, thawing, and other manipulations, while maintaining biological properties).
cell therapy product
A fertilized oocyte (or segmented cells) from the moment of fertilization to the point of time at which all organs of the given organism have developed embryologically.
A cell derived from developing blastocysts that has the capacity to differentiate to every cell type found in the body.
embryonic stem cell
A specific class of tissue-specific stem cells that and can give rise to differentiated cells of all hematopoietic lineages, myeloid and lymphoid, either in the hematopoietic bone marrow or in the thymus.
hematopoietic stem cell (HSC) / progenitor cell (HPC):
Repair, replacement or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic functions in the recipient as in the donor
Peripheral blood collected by apheresis as a source of hematopoietic progenitor cells.
Umbilical cord blood and/or placental blood collected as a source of hematopoietic progenitor cells.
HPC, Cord blood
Bone marrow collected as a source of hematopoietic progenitor cells.
A type of pluripotent stem cell, similar to an embryonic stem cell, formed by the introduction of certain embryonic genes into a somatic cell.
Induced pluripotent stem cell (iPsc)
A multipotent, non-haematopoietic stem cell found in a variety of tissues such as bone marrow stroma, umbilical cord blood and adipose tissue, capable of producing mesenchymal lineages, mainly osteogenic, chondrogenic and adipogenic lineages.
mesenchymal stem cell (msc) / stromal cell
The state of a cell that has the ability to develop into more than one cell type of the body, but is lineage-committed.
The state of a cell that is capable of differentiating into all tissues of an organism, but not alone capable of sustaining full organismal development.
Autologous, allogeneic, or xenogeneic cells that have been propagated, expanded, selected, pharmacologically treated, or otherwise altered in biological characteristics ex vivo to be administered to humans and applicable to the prevention, treatment, cure, diagnosis or mitigation of disease or injuries.
somatic cell therapy
A population of cells that can be grown indefinitely and has the ability to differentiate into various types of cells if the culture conditions are met.
stem cell line
The state of a cell that is capable of giving rise to all types of differentiated cells found in an organism, as well as the supporting extra-embryonic structures of the placenta. A single totipotent cell could, by division in utero, reproduce the whole organism.
The percentage from the ratio of the number unstained (viable) cells to the total number of cells, after incubation with viability dyes such as Trypan blue. Automated methods such as flow cytometry can also be used for determination.
Contains or consists of a live non-human animal cell, tissue, organ or their derivative intended to be used as an active ingredient in the manufacture of a cell- and tissue-based therapeutic product; AND is intended to be used for or administered to humans.
Any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs.
Live cells, tissues or organs used in xenotransplantation.