SBIR Phase I: Arthroscopy Delivered Scaffolds to Repair and Regenerate Meniscus for Aging Patients

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to prevent or reduce the high risk of post-meniscectomy osteoarthritis (OA) following partial meniscectomy which is a popular treatment for meniscus tears. Meniscus tears represent common lesions injuries prevailing in ~36% of people with ages at and greater than 45 years old, but with few effective treatments. Meniscectomy is performed to temporarily relieve the severe pain and other symptoms associated with meniscus tears. Over one million patients undergo meniscectomy to palliate painful symptoms associating torn meniscus each year in the U.S. The drawback of meniscectomy is significant increases of incidence of osteoarthritis (OA) later in life (by as high as 7 folds), because loss of meniscus causes altered load transmission, decreased shock absorption, and decreased joint stability and increased joint cartilage contact stress. Post-meniscectomy osteoarthritis (OA) is well documented in literatures. OA is more challenging to treat and incur more costly expenditures and causes more severe physical sufferings for patients. There is urgent need for effective treatment for meniscus tears while reducing or preventing the poste-meniscectomy risks. The proposed project could, if successful, potentially address the unmet clinical need by developing a device precisely repairing and regenerating the torn meniscus and restoring the biomechanical functionality. No existing knowledge teaches how an aging joint environment may affect the meniscal repair and regeneration, and neither the applicants? previous study can tell how their new device may perform in the aging joints; both scientific evidence and necessary technical solutions are unclear yet. The present Phase I study will: 1) determine the delivery strategy to stimulate reparative stem cells in aging knees, and 2) determine the delivery strategy under additional inflammatory stress, using in vitro evaluation models. The study serves as a critical step of proof-of-concept for future translation of the technology into a clinical application.