ROOSTERBIO, INC. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

DESCRIPTION provided by applicant Mesenchymal Stem Cells or MSC will be key components of future therapeutics engineered tissues and medical devices There are currently over clinical trials CT investigating MSC as therapies The CT have produced some promising results with MSC generally deemed safe and effective The promise of MSC has resulted in an increased demand for research and clinical grade MSC However commercially available cells for research are not well suited for translational work and clinical grade cells are not available to purchase RoosterBio Inc was founded to reduce the costs and complexity of developing and implementing MSC technology for clinical translation and we have recently brought to market affordable and well characterized human bone marrow derived MSC in translation ready formats Recently exciting research from many investigators has shown that culture of MSC as D aggregates DhMSC improves in vitro biological activity over MSC grown as a monolayer D hMSC including enhanced differentiation and increased paracrine factor secretion D MSC also have enhanced therapeutic properties in pre clinical models Due to the therapeutic potential of D MSC RoosterBio aims to provide researchers with affordable access to translationally relevant D hMSC aggregates that are ready for pre clinical use hMSC aggregates D hMSC are currently produced by expanding cells in conventional D culture isolating cells and forming aggregates in a separate vessel through several non scalable methods For D hMSC to become a commercial product methods have to be developed that can produce D hMSC using scalable cost effective and regulatory friendly processes In this Phase I SBIR we will test the feasibility of an innovative technology developed in the T Ma laboratory FSU to grow MSC and produce D hMSC on microcarriers with thermo reversible surfaces TRM The Ma lab has synthesized TRM and produced D hMSC at small scale in culture dishes We predict that TRM are compatible with sitrred tank bioreactors and thus are scalable to hundreds of liters in single use vessels thus enabling commercial production of D hMSC We propose experiments to develop this innovative TRM bioreactor technology The milestone at the end of this Phase I SBIR will be to demonstrate that a TRM Bioreactor can produce D hMSC that maintain therapeutically relevant properties of D hMSC produced by standard methods This work will set the stage for a Phase grant to optimize the production process and scale up the TRM Bioreactor based technology for a commercial scale andquot ready to useandquot D hMSC product that will provide translational scientists engineers and bioprinters access to high quality affordable hMSC with enhanced function Importantly these processes will also be translatable to clinical production of D hMSC Project Narrative Results from basic research and clinical trials show that Mesenchymal Stem Cells MSC will be a key component of future therapeutics for a wide variety of diseases and conditions Recently investigators have found that multi cellular aggregates of MSC termed D MSC improves biological and therapeutic activity of the MSC in vitro and in vivo relative to MSC grown as a monolayer D MSC Experiments in this proposal done by RoosterBio Inc will develop protocols to produce D hMSC using scalable cost effective and regulatory friendly processes This ready to use D hMSC product will provide translational scientists engineers clinicians and bioprinters access to high quality and affordable hMSC with enhanced function