SBIR-STTR Award

(Adapted from the applicant's abstract) Removal of anti-A and anti-B antibodies from individuals should allow for renal organ transplantation without the restriction of ABO matching. The proposed device would accomplish this in a simple, highly biocompatible way, and with greater efficacy than other methods. This device consists of a hollow fiber filter system similar to traditional renal dialysis with synthetic blood group A and B substances attached to the lumenal surfaces. The ABO incompatible recipient would have their blood passed through the filter in a similar fashion to routine renal dialysis. Anti-A and anti-B antibodies will bind to the blood group A and B substances lining the lumenal surface of the filter. If high levels of anti-A and anti-B antibodies are [lowered to 1:2 level] in the peritransplant period, hyper- acute rejection can be eliminated and graft survival can be accomplished. The advantage of this technique included the increased biocompatibility achieved by the removal of antibody from whole blood as opposed to plasmapheresis followed by treatment with beaded columns and additionally the unique flow characteristics of hollow fibers allow for increased removal of antibodies via ultrafiltration. The device would increase the pool of living related and unrelated donors.Proposed Commercial Application:Not avaliable

Thesaurus Terms:
biomedical equipment development, blood group antigen, blood treatment, clinical biomedical equipment, isoantibody, kidney transplantation, method development clinical research, hollow fiber separation technique, human subject

Renal transplant remains superior to chronic renal dialysis. Organ availability is the largest hurdle to transplant for thousands of individuals per year. A device which safely removes anti-A and anti-B antibodies may significantly increase organ availability by reducing or eliminating ABO matching requirements. There are no FDA-approved devices which achieve this goal. The investigator has demonstrated the feasibility of a prototype device which removes anti-A and anti-B antibodies from whole human blood during a Phase I trial. The device is simple, biocompatible, and generates reproducible results. This Phase II research is designed to produce a device to remove anti-A and anti-B antibodies in vivo with the safety profile acceptably similar to routine devices. A successful collaboration with the McGowan Center for Artificial Organ Development at the University of Pittsburgh Medical Center was instrumental in the successful completion of Phase I of this project. This collaborative effort will be expanded during the proposed Phase II. Additional collaborations, crucial to the successful completion of this project, are with Bend Research Inc. (membrane and advance separations sciences), and Source Pharmaceuticals (synthesis of blood group antigens).

Thesaurus Terms:
biomedical equipment development, blood group antigen, blood treatment, clinical biomedical equipment, isoantibody, kidney transplantation blood chemistry clinical research, hollow fiber separation technique, human subject