A High Performance Point-of-Care Device for Umbilical Cord Blood Processing

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$150,000.00
Award Year:
2012
Program:
SBIR
Phase:
Phase I
Contract:
1R43OD016688-01A1
Award Id:
n/a
Agency Tracking Number:
R43OD016688
Solicitation Year:
2012
Solicitation Topic Code:
OD
Solicitation Number:
PA11-096
Small Business Information
One Innovation Drive, Worcester, MA, 01605-4307
Hubzone Owned:
N
Minority Owned:
Y
Woman Owned:
N
Duns:
962130485
Principal Investigator:
LOTIENHUANG
(617) 682-8981
rhu@cytovera.com
Business Contact:
LOTIENHUANG
(617) 682-8981
rhu@cytovera.com
Research Institute:
Stub




Abstract
DESCRIPTION (provided by applicant): This project aims to develop a novel microfluidic device that preserves the maximal viability and potency of cord blood stem cells, in order to render cord blood transplantation effective for adult patients with leukemia, lymphoma, and other serious blood and bone marrow diseases. Currently cord blood transplantation yields good outcomes in children (50% - 70% one year survival), and has been shown to have significant advantages over other types of stem cell transplantation. However, cord blood transplantation in adults suffers poor outcomes (~20% one year survival). It is estimated that the dosage of potent stem cells has to be increased by a factor of 3 for adult cord blood transplantation to yield satisfactory outcomes, due to the larger body weights of adult patients. Studies have shown that the current cord blood processing and banking practices lead to as much as ~90% loss in cell potency, particularly during the shipping delay (36 to 48 hrs) and the centrifugal volume reduction step, leaving only 10 - 20% of the original cell potency by the time a unit arrives at a processing facility. The new device proposed here will enable immediate processing of cord blood at point of care, thereby eliminating the loss in viability and potency. The device will be based on a hydrodynamic effect observed in natural blood circulation to allow for gentle and physiological separation of cells. Early prototypes have achieved better initial results than conventional methods: gt90% totalnucleated cells were recovered with no detectable loss in cell viability (n = 6). Phase I of this project aims to demonstrate the high viability and potency of th cord blood stem cells enriched using an improved prototype device. Phase II aims to optimizethe prototype device, validate its safety and effectiveness, and benchmark its performance against standard centrifugation-based systems. Potential impacts of the device include enabling cord blood to replace bone marrow as the primary source of stem cellsfor transplantation, delivering significantly better patient outcomes, and making cord blood banking and stem cell therapies much more effective. PUBLIC HEALTH RELEVANCE: This project aims to develop a novel device that preserves the maximal viability and potency of cord blood stem cells, in order to render cord blood transplantation effective for adult patients. The proposed device will potentially enable cord blood to replace bone marrow and peripheral blood stem cells as the standard source ofstem cells, providing significantly better outcomes and long term survival to patients with leukemia, lymphoma, and many other serious diseases.

* information listed above is at the time of submission.

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