Development of effective in-office autologouscell therapy for osteoarthritis

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PROJECT SUMMARY Osteoarthritis is today a major worldwide challenge for health systems, representing the most common degenerative joint disorder and the leading cause of chronic disability among older adults. In the U.S. alone, OA affects 30 million people and it represents a $303 billion economic burden. Available pharmacological treatments only provide symptomatic pain relief and fail to arrest the progressive degeneration of cartilage associated with OA. Surgical 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 complications. JointechLabs (JTL) proposes an innovative regenerative protocol for OA that could be easily implemented at POC (Point Of Care). JTL approach to OA combines for the first time the regenerative healing properties of stem cells and the benefits of long-lasting viscosupplementation. The innovation proposed resides on the unique combination of two components developed by JTL: 1) A unique portable and disposable closed system for the preparation and harvest of Autologous Adipose-Derived Stem Cells (ADSCs) in non-controlled environments; 2) The first clinically approved viscosupplement product that can act as a scaffold to support stem cells growth. This combination will allow the articular injection of Autologous ADSCs isolated at the bedside and encapsulated in a protective hydrogel, which will support and accelerate the release of regenerative cellular factors to promote joint healing in OA. At the same time, the proprietary gel will provide lubrication for pain relief, creating a favorable environment for general therapeutic effect. The goal of this SBIR Phase I proposal is to demonstrate the feasibility of the proposed approach as a new treatment of OA. We propose the following specific aims: 1) Identification of the most favorable combination of hydrogel carrier and ADSCs concentrations to support high regenerative potential. 2) Validation of regenerative protocol using an in vitro model of inflamed human joints. At the same time, evidence of the mechanism of action will be collected at the molecular level to gain accurate information before moving forward into clinical studies. The 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-in- human clinical study to validate safety and efficacy of the treatment for OA.