The CliniMACS system in combination with a CliniMACS Tubing Set and CliniMACS CD34 Reagent is being investigated for use in selecting and enriching human CD34 positive hematopoietic progenitor cells from leukapheresis products.
The CD34 antigen is a cell membrane glycoprotein expressed by early hematopoietic progenitor cells. Investigative studies with the CliniMACS device have suggested that when re-infused after myeloablative chemotherapy, CD34 positive peripheral blood progenitor cells have been shown to reconstitute all lineages.1
The CliniMACS system in combination with the CliniMACS Tubing Set and CliniMACS CD34 Reagent is expected to work in following manner. It takes advantage of the selectivity of monoclonal CD34 antibodies conjugated to magnetic particles. The CD34 positive target cells are selected in an automated separation system.
For labeling of the CD34 positive cells, the leukapheresis product is incubated with the CliniMACS CD34 Reagent. After washing away the excess unbound Reagent the automated selection is started.
The CliniMACS system passes the antibody-labeled suspension through a column in which strong magnetic gradients are generated. The column retains the magnetically labeled CD34 positive cells, while unwanted cells flow through and are collected in the negative fraction bag.The system performs several washing steps disposing of most of the liquid into the buffer waste bag. The selected CD34 positive cells are released from the column by removing the column from the magnetic field and eluting the cells into the cell collection bag.
In the USA, the CliniMACS® System components (Reagents, Tubing Sets, Instruments and PBS/EDTA Buffer) are available for use under an approved Investigational New Drug (IND) application or Investigational Device Exemption (IDE).
The components of the CliniMACS Prodigy line are for research use only and not for human therapeutic or diagnostic use.
References:1. Bone Marrow Transplant (2000) 25: 243-249