Development of effective in-office autologouscell therapy for osteoarthritis

PROJECT SUMMARY Osteoarthritis is today a major worldwide challenge for health systemsrepresenting the most common degenerative joint disorder and the leading cause of chronic disability among older adultsIn the U SaloneOA affectsmillion people and it represents a $billion economic burdenAvailable pharmacological treatments only provide symptomatic pain relief and fail to arrest the progressive degeneration of cartilage associated with OASurgical procedures that promote cartilage repair by implantation of artificial joint structures are expensive procedures that require long rehabilitation and might expose patients to the risk of complicationsJointechLabsJTLproposes an innovative regenerative protocol for OA that could be easily implemented at POCPoint Of CareJTL approach to OA combines for the first time the regenerative healing properties of stem cells and the benefits of long lasting viscosupplementationThe innovation proposed resides on the unique combination of two components developed by JTLA unique portable and disposable closed system for the preparation and harvest of Autologous Adipose Derived Stem CellsADSCsin non controlled environmentsThe first clinically approved viscosupplement product that can act as a scaffold to support stem cells growthThis combination will allow the articular injection of Autologous ADSCs isolated at the bedside and encapsulated in a protective hydrogelwhich will support and accelerate the release of regenerative cellular factors to promote joint healing in OAAt the same timethe proprietary gel will provide lubrication for pain reliefcreating a favorable environment for general therapeutic effectThe goal of this SBIR Phase I proposal is to demonstrate the feasibility of the proposed approach as a new treatment of OAWe propose the following specific aimsIdentification of the most favorable combination of hydrogel carrier and ADSCs concentrations to support high regenerative potentialValidation of regenerative protocol using an in vitro model of inflamed human jointsAt the same timeevidence of the mechanism of action will be collected at the molecular level to gain accurate information before moving forward into clinical studiesThe successful completion of this SBIR Phase I project will lay the foundation of a Phase II SBIR proposal that will address key technical product developments in support of IND application that will open the way to a first inhuman clinical study to validate safety and efficacy of the treatment for OA PROJECT NARRATIVE OsteoarthritisOAis the most common joint disorder worldwide and it is the leading cause of chronic disability among older adultsJointechLabs is developing a clinically reliable regenerative protocol based on the combination of long lasting viscosupplement and autologous stem cellsThe approach of JTL will have unprecedented efficacy and it will be easily implemented at Point Of Care and will provide long lasting effects to prevent the need for surgical intervention