SBIR/STTR Award attributes
Project Summary Abstract This Phase II project aims to develop an automated system for extracting mesenchymal stem cellsMSCsalso known as multipotent stromal cellsfrom adipose tissues for treating many serious diseasesincluding myocardial infarctiongraft versus host diseaseand a variety of autoimmune diseasesOverclinical trials to date have established the feasibilitysafetyand in some cases efficacy of MSC therapies to treat these diseasesHoweverthe results are inconclusive due tothe lack of reliable and optimized MSC preparation protocolsandthe loss of therapeutic potential as MSCs are extensively culture expandedBased on its patent pending technologyCG Scientific Incis developing an automated MSC extraction system that provides high cell recovery and viabilitywhile significantly reducing process variationstimeand costsThe company has successfully demonstrated in Phase I that its technology can deliver aboutmillion MSCs inminutes from a single adipose specimensufficient to provide a therapeutic dose of MSCs without culture expansionThis result represents ax improvement in MSC output yield over competing productsdue tox in cell recovery andx in MSC functionand opens the opportunity to use un cultured primary MSCs as a high potency substitute for conventional culture expanded MSCsWithout culture expansionit becomes possible to produce sufficient therapeutic amounts of MSCs in less thanhouras opposed toweeks conventionallyand administer the MSCs autologously in the same dayThe automated system has a unique configuration toenable efficient enzyme digestionintegrate multiple MSC extraction steps in a closed system formatfully automate the MSC extraction processandovercome conventional limitations of enzymatic cell extractionUsing the technologyhigh quality MSCs can be produced in clinically relevant quantities quicklysafelyand reproduciblyIn Phase IIthe company willdevelop a final product prototype to work out manufacturing details and further optimize MSC recovery performancecharacterize the new system and prepare data for FDA submissionanddemonstrate the pre clinical efficacy and the superior performance of the new system against competing productsThe investigator team includes medical device expertsstem cell biologistsengineers and medical doctors who have worked together successfullyThis project will result in the realization of an essential tool that has the potential to make MSC therapies highly effective and practical for treating many life threatening and hard to treat diseases Project Narrative This Phase II project aims to develop a novel automated system for high efficiency extraction of mesenchymal stem cellsMSCsfrom adipose tissuesThe system will provide sufficient clinical doses of potent MSCs with no culture expansion for effective treatments of many life threatening diseasesincluding myocardial infarctiondiabetesliver cirrhosisgraft versus host diseaseGVHDand a variety of autoimmune diseasesThe proposed automated system represents an essential tool for potentially enabling MSC therapies to become highly effective and practical for treating many serious diseases
