SBIR-STTR Award

Applied Immune Sciences, Inc. has developed sterile polystyrene devices onto which monoclonal antibodies are covalently attached. These devices are routinely used to rapidly separate cells with surface antigens specific for the inunobilized antibody. Moreover, these devices have been used successfully to purify hematopoietic stem cells from human bone marrow.The specific aim of this research is to use these devices to efficiently collect peripheral blood-stem cells from autologous transplant candidates, thereby creating a nontoxic generic procedure to prepare purged grafts. Moreover, it is the purpose of this research to determine the long term hematopoietic potential of such purified peripheral blood stem cells. If this research is successful, the long term goal is to develop large surface area devices which will efficiently and rapidly process the numbers of cells required for a full size transplant.Autologous transplant with purified peripheral blood stem cells will offer several advantages to patients: 1) Collection of peripheral blood could take place without general anesthesia, 2) The total number of stem c ells collected and thereby transplanted will be greater, 3) In many diseases, the peripheral blood is less contaminated with tumor cells, 4) The purified CD34+ stem cells will serve as a purged source of engraftable material, and 5) Animal experiments indicate that more rapid engraftment may take place with purified stem cells. Because of these advantages, commercialization of these devices should be possible.Awardee's statement of the potential commercial applications of the research:The research will explore the purification of peripheral blood hematopoietic stem cells and the long term hematopoietic capabilities of these purified cells. Development of such a process would provide patients with a generic and easy method to collect autologous stem cell grafts which are purged of tumor cells.National Heart, Lung and Blood Institute (NHLBI)

We have developed sterile polystyrene devices onto which monoclonal antibodies are covalently attached. These devices have been routinely used to separate cells from blood and bone marrow which have surface antigens specific for the immobilized antibody. Moreover, these devices are effective in isolating hematopoietic stem cells from bone marrow and peripheral blood. The specific aim of this research proposal is to develop large scale cell separation devices based on our existing technology to efficiently purify peripheral blood stem cells in sufficient quantity for transplant. The procedure would provide a nontoxic, noninvasive procedure purged grafts. Autologous transplant with purified peripheral blood stem cells will offer several advantages to patients: 1) collection of peripheral blood will take place in an apheresis center without general anesthesia; 2) in many cases the total number of stem cells collected and transplanted will be greater, 3) in many diseases the peripheral blood is less contaminated with tumor cells than is the bone marrow; 4) the purified stem cells will be purged of residual tumor cells; 50 patients will be grafted with 100 fold smaller cell volumes, substantially reducing DMSO toxicities; 60 animal experiments show that more rapid engraftment of myeloid cells may occur using purified stem cell grafts. Use of purified stem cells also dramatically reduces the storage space required in transplant units. Because of these advantages, commercialization of these devices should be possible.Awardee's statement of the potential commercial applications of the research: The research is directed towards the development of large scale cell separation devices capable of isolating to high purity, rare populations within peripheral blood. The targeted population in this case in peripheral blood stem cells. Other applications for the technology would be for the collection of cord blood stem cells, the isolation to fetal cells from maternal blood for diagnostic purposes, or the capture of antigen specific T cells for adoptive immunotherapy protocols. The system could eventually be expanded for both the capture and culture of rare populations.National Heart, Lung, and Blood Institute (NHLBI)