AUTOMATED CLOSED SYSTEM FOR DMSO REMOVAL FROM PERIPHERAL BLOOD STEM CELLS

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43HL083669-01
Agency Tracking Number: HL083669
Amount: $133,734.00
Phase: Phase I
Program: SBIR
Awards Year: 2006
Solicitation Year: 2006
Solicitation Topic Code: N/A
Solicitation Number: PHS2006-2
Small Business Information
GENERAL BIOTECHNOLOGY, LLC
1102 STADIUM DR., INDIANAPOLIS, IN, 46202
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 ERIK WOODS
 (317) 917-3450
 ERIK@GNRLBIOTECH.COM
Business Contact
 JOHN CRITSER
Phone: (317) 917-3450
Email: CRITSERJ@MISSOURI.EDU
Research Institution
N/A
Abstract
DESCRIPTION (provided by applicant): High dose chemotherapy followed by peripheral blood hematopoietic stem cell (PBSC) transplantation is frequently used for treating various hematologic malignancies. To facilitate this process, autologous PBSC are typically collected, cryopreserved and stored for some period of time. Current PBSC cryopreservation requires the use of molar concentrations of the cryoprotectant additive dimethyl sulfoxide (DMSO). Typically, frozen-thawed cells are transplanted back into patients along with DMSO. However, reinfusion of DMSO has long been associated with various adverse events, ranging from skin flushing, headache, fever, dyspnea, abdominal cramping, nausea, and diarrhea to more sever effects such as, hemolysis, cardiovascular symptoms and cerebrovascular ischemia leading to neurological events. These can result in increased morbidity, prolonged hospitalization, and increased treatment-related costs. Currently, when removal of DMSO is attempted, the procedures typically involve cell "washing" using centrifugation. These methods introduce mechanical forces and osmotic stress causing cell packing/clumping and potential significant cell loss. They also require additional laboratory staff as well, and take between 3 and 4 hours of work per patient, which makes the procedure more expensive and practically difficult for many institutions. Finally, it is difficult to keep the cells in a "closed" system during cell washing, which may lead to contamination. It is the goal of this proposal to refine and optimize an automated, portable, closed-system diffusion-driven washing device for use in clearance of DMSO from PBSC, to prevent infusion of DMSO into patients during clinical transplant without loss of cell numbers or cell functionality. In this Phase I research, the device will be optimized for effective clearance of DMSO from cell suspension solutions while allowing high cell recovery with maintenance of cell functional viability as assessed by in vitro clonogenic ability as well as engraftment in a NOD/SCID mouse model.

* information listed above is at the time of submission.

Agency Micro-sites

SBA logo
Department of Agriculture logo
Department of Commerce logo
Department of Defense logo
Department of Education logo
Department of Energy logo
Department of Health and Human Services logo
Department of Homeland Security logo
Department of Transportation logo
Environmental Protection Agency logo
National Aeronautics and Space Administration logo
National Science Foundation logo
US Flag An Official Website of the United States Government