Cell-Generated Matrix (CGEM) Graft for Anterior Cruciate Ligament Repair.

IntroductionSTEL TechnologiesLLC is a Regenerative Medicine company founded in AprilThe founders STEL are researchers at the University of MichiganSTEL s first productthe CGEMgraft is an innovative and paradigm shifting approach to ligament tissue engineering and a unique biological replacement for the anterior cruciate ligamentACLinjuriesSignificanceMore thanACL reconstruction surgeries are performed each year in the U SIn addition to the high cost of the procedurethese patients are at high risk of developing osteoarthritisOAwithin a decade after surgeryWith the increase in pediatric ACL injuriesthe long term costs and quality of life implications will be an increasing healthcare issue until improvements in treatment are developedThe current state of the art in torn ACL management is either non surgicalconservative treatment or surgical repairThe current grafts used for repair don t restore normal functionearly onset OA remains a risk and is seen in aboutof treated casesProductThe CGEMcell generated matrixgraft is a devitalized allogeneic tissue engineered combination tissue produced from differentiated bone marrow derived mesenchymal stem cellsMSCsand assembled in a proprietary semiclosedD tissue production systemThe unique compositional and mechanical properties of the CGEMTM graft allow the patient s body to regrow native ACL tissue that results ina reduced incidence of short term graft failuresltmonths post surgeryimproved knee stability atmonthsmeasured by joint laxity and clinical evaluationandimproved knee function atmonthsevaluated by gait and muscle functionThe CGEMTM graft can restore near normal form and function to an ACL injured knee and eliminate the donor site pain and disability associated with autografts and graft failure risks associated with allograftsIn implantation studies of these constructs in sheepthe graft achievessuccess in spanning the native ACL site and integrating with native boneGoalThis PhaseSBIR proposal will continue the success of our PhaseSTTR towards developing our CGEMgraft fabrication methodologies to obtain a product suitable for human useThe development of the product lies in three areas and will comprise the three aims of this current proposal presented belowAimTo scale up the CGEMgraft to a size applicable for adult humans and confirm comparability of preclinical sheep derived grafts with clinical CGEMgraftAimTo confirm the identitypotencyqualitypurityand sterility of the clinical CGEMgraft with the ultimate goal of defining the release criteria for the clinical CGEMgraftAimTo characterize a Master Cell Bank for the clinical CGEMgraftExpected OutcomesConfirmation that the CGEMgraft can be scaled up in a reproduciblequality and sterile way will provide the necessary assurance safety and efficacy data to apply for a first in humans study with the FDAThe success of this PhaseSBIR project will result in the development of anoff the shelfhuman ligament graft ready for use in ACL repairs