GVHD can damage different parts of the body, including the liver, skin, mucosa, and gastrointestinal tract. Symptoms can include rashes, intestinal inflammation, severe diarrhea, nausea, and vomiting
GVHD is divided into two categories: acute and chronic. Whereas acute GVHD is normally observed within the first 100 days after transplantation, chronic GVHD occurs after 100 days and in some cases, may occur years after transplantation as a long-term side effect of the treatment
The course of GVHD varies from mild to severe and can even be a life-threatening disease. When GVHD becomes a chronic disease, it is frequently accompanied by a dramatic decrease in the patient’s quality of life.
Cell types of the human body can be identified by the molecules they bear on their surface. Human blood stem cells are often characterized by a protein marker they bear on their surface called CD34. By coupling a magnetic particle (comprised of iron and dextran, a sugar molecule) to an antibody that is capable of binding very specifically to the CD34 surface marker, stem cells can be separated from other cells when placed in a magnetic field within the medical device.
The preparation of a T cell depleted graft for transplantation involves a series of steps
Authorized by U.S. Federal Law for use in the treatment of patients with acute myeloid leukemia (AML) in first complete remission. The effectiveness of the device for this use has not been demonstrated.
Indications for Use
The CliniMACS® CD34 Reagent System is indicated for processing hematopoietic progenitor cells collected by apheresis (HPC, Apheresis) from an allogeneic, HLA-identical, sibling donor to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft versus host disease (GVHD) prophylaxis in patients with acute myeloid leukemia (AML) in first morphologic complete remission.
Do not use CD34+ cells prepared with CliniMACS CD34 Reagent System in patients with known hypersensitivity to murine (mouse) proteins or iron dextran.