AmnioWell(Amniotic Fluid) is described as an all natural acellular allograft intended for homologous use.
The clinical term acellular is medically defined as”not made up of cells or divided into cells.” Otherwise, lacking intact cells as, for example, an acellular vaccine which may contain cellular material, but not complete cells.
An allograft is defined as a transplant of an organ or tissue from one individual to another of the same species with a different genotype. For example, a transplant from one person to another, but not an identical twin, is an allograft. Allografts account for many human transplants, including those from cadaveric, living related, and living unrelated donors. Also known as an allogeneic graft or a homograft.
“Homologous use” describes a human cellular or tissue product (HCT/P) used clinically in a manner that is essentially the same as the natural endogenous function that it performed.
AmnioWell(AF), amniotic derived protein matrix is not classified as a drug but a tissue donation and falls under the (HCT/P’s) Biologic code.
