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AUTOMATED CLOSED SYSTEM FOR DMSO REMOVAL FROM PERIPHERAL BLOOD STEM CELLS

Award Number: R43HL083669
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: HEALTH SERVICES
PERIOD OF PERFORMANCE START DATE: 02/01/2006
PERIOD OF PERFORMANCE END DATE: 01/31/2007

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AUTOMATED CLOSED SYSTEM FOR DMSO REMOVAL FROM PERIPHERAL BLOOD STEM CELLS - 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2006 ( Subtotal = $133,734 )
2006	2006	GENERAL BIOTECHNOLOGY	1102 STADIUM DRIVE	INDIANAPOLIS	IN	46202	MARION	USA	Blood Diseases and Resources Research	000	1	1/31/2006	NEW	$133,734
														Subtotal = $133,734

Grand Total All Awards = $133,734

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AUTOMATED CLOSED SYSTEM FOR DMSO REMOVAL FROM PERIPHERAL BLOOD STEM CELLS

Award Number: R43HL083669

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: HEALTH SERVICES

PERIOD OF PERFORMANCE START DATE: 02/01/2006

PERIOD OF PERFORMANCE END DATE: 01/31/2007

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