Description
The CliniMACS® CD34 Reagent System consists of the following components:
- CliniMACS Plus Instrument
- CliniMACS CD34 Reagent
- CliniMACS Tubing Set (normal scale: TS or large scale: TSLS)
- CliniMACS PBS/EDTA Buffer
The CliniMACS Plus Instrument
The CliniMACS Plus Instrument is an automated cell separation system based on MACS® Technology. It enables the operator to perform clinical-scale magnetic enrichment of target cells (CD34+ cells) in a closed and sterile system. The CliniMACS Plus offers reliability and convenience in one compact benchtop instrument.
Cells are magnetically labeled in the Cell Preparation Bag using an antigen-specific reagent. Subsequently, the Cell Preparation Bag is connected to the CliniMACS Plus Instrument. Consumer-friendly software facilitates CD34+ cell enrichment, as well as the collection of the CD34+ cells in the Cell Collection Bag. The CliniMACS CD34 Reagent System separates large numbers of CD34+ cells providing target cells with high purity and excellent yield.
The CliniMACS CD34 Reagent
The CliniMACS CD34 Reagent was developed for the enrichment of CD34+ cells from progenitor cells collected by apheresis (HPC, Apheresis) in combination with the CliniMACS CD34 Reagent System. The CD34 antigen is a single transmembrane glycoprotein that is mainly expressed on human hematopoietic stem and progenitor cells but is also present on endothelial progenitor cells. The CliniMACS CD34 Reagent consists of murine anti-CD34 monoclonal antibodies conjugated to superparamagnetic iron dextran particles.
The CliniMACS Tubing Sets (TS and TSLS)
CliniMACS® Tubing Sets (TS and TSLS) consist of pre-assembled tubing including a pre-column and a separation column. The fluid path of the tubing sets is sterile and non-pyrogenic.
The CliniMACS Tubing Sets (TS and TSLS) are used for the enrichment of CD34+ cells from HPC, Apheresis in combination with the CliniMACS CD34 Reagent System.
The CliniMACS PBS/EDTA Buffer
The CliniMACS® PBS/EDTA Buffer consists of phosphate-buffered saline, pH 7.2, supplemented with 1 mM EDTA. The buffer is supplied in 1 L plastic bags as a sterile, non-pyrogenic solution. The CliniMACS PBS/EDTA Buffer was developed for cell preparation and separation of magnetically labeled cells for use with the CliniMACS CD34 Reagent System. CliniMACS PBS/EDTA Buffer is not intended for direct infusion into humans.
Referenced literature
CD34 enrichment of progenitor cells is performed to provide an allogeneic stem cell graft that is highly purified for CD34+ cells and depleted of unwanted T cells.
A reproducible T cell depletion was demonstrated in a multicenter setting using the CliniMACS CD34 Reagent System.1 Furthermore, the role of T cell depletion (TCD) with the CliniMACS CD34 Reagent System was investigated in a multicenter study (BMT CTN 0303), resulting in low risk of extensive chronic GVHD and relapse for patients with AML in CR1.2 Comparison of these data with a similar study in which patients had received a hematopoietic stem cell graft that was not T cell–depleted (BMT CTN 0101) showed that TCD with the CliniMACS CD34 Reagent System, as the sole method for preventing GVHD, resulted in a lower incidence of acute and chronic GVHD in patients. This method of T cell depletion did not have any negative impact on engraftment success, patient survival, or relapse rate.3
Disclaimer
HUMANITARIAN DEVICE: 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.
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.
Overview
The CliniMACS CD34 Reagent System is a medical device system that is designed for the in vitro enrichment of CD34+ target cells from heterogeneous hematologic cell populations. The process of CD34+ cell selection results in simultaneous passive depletion of donor lymphocytes, potentially obviating the need for immunosuppressive drugs to prevent GVHD.
