DIAGNOLOGIX, LLC — Department of Health and Human Services SBIR Phase II: NHLBI

Description

Umbilical cord bloodUCBhas been an alternative source for patients with hematologic diseases who may be potentially cured by allogeneic hematopoietic cell transplantationIn additionUCB is an important stem cell source for other promising technologiessuch as large scale ex vivo productions of hematopoietic stem cellHSCderived red blood cells and plateletsIn theyears following the first successful case of transplantation inmore thanUCB transplantations have been performed with rtUCB units stored worldwideInitiallyUCB transplantation was mainly performed in childrengiven the concern of low cell doseAs cell dose is critical for engraftment and survivalinfusing two units of UCB has been a popular practice for adult patientsHoweverthis approach makes HLA matching even more challengingRemarkablyit has been estimated that current total UCB collections represent ltof potentially available cordsThereforethere is an unmet need for innovative and low cost solutions to increase the number and HLA diversity of banked UCB unitsas well as to overcome the cell dose limitation of each UCB unitFurthermorean international survey conducted by the World Marrow Donor Association inrevealed that nearlyof public UCB banks are not financially sustainableRecentlywe have developed an innovative microbubblebased technology for rare cell isolation in blood that can help resolve these issuesWe use perfluorocarbonfilled microbubblesMBswhich have been used as a safe ultrasound contrast agentto create targeted agents for sortingThereforethis material would be suitable for isolating cells for therapeutic applicationsWe will create the targeted microbubble based system to isolate HSCswhich leads to substantial reduction of the final product volumeltmlcompared to current standard unitrtmlfor bankingThis factor alone will lead to rtfold savings on long term storage in liquid nitrogenThe simplicity of the procedure has been shown in publicationsand reduction of the cost may revolutionize the UCB banking industry to facilitate realization of emerging innovations in cell based therapiesaside from more conventional hematopoietic cell transplantationWe have accomplished key feasibility milestones for the phase I grant and will develop a closed system to isolate HSCs from UCB for potential clinical applicationsincluding hematopoietic transplantation and ex vivo blood productionMoreoverthis system can also be conveniently adapted for HSC isolation from other sourcesincluding peripheral blood and bone marrow