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Device Design and Development
Team Leader Alex Slocum, Ph.D., Massachusetts Institute of Technology
Manufacturing Team TNCO
Karin Gilman, Frank DiFrancesco, Jerry Griffiths, Matthew Attar, Chris Johnson
Advisor Jonathan J. Rosen, Ph.D., Director, Office of Technology Implementation, CIMIT
Funding CIMIT
Massachusetts Technology Transfer Center
Children's Orthopaedic Surgical Foundation
Development Team
Development Team
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Treatment of intra-articular tissue defects (including those of the ACL, meniscus and articular cartilage) remain one of the most challenging problems facing orthopedic science today.

Our work has focused on studying the regenerative potential of native tissues after injury. We have found that the cells in each of these tissues have great potential for proliferation, extra-cellular matrix production and migration if provided with the right environment. We have identified the premature loss of fibrin clot (secondary to the presence of plasmin in the synovial fluid) as the likely etiology of the failure of these tissues to heal.

We hypothesize that placement of a substitute provisional scaffold which is resistant to plasmin degradation and can facilitate cell migration, proliferation and collagen production will result in healing and repair of these tissues.

In Vivo Testing
In vitro testing of various candidate provisional scaffolds led us to adopt the use of a scaffold which combines fibrous Type I collagen and autologous platelet-rich-plasma. This material facilitates cell migration, proliferation and extracellular matrix production - all processes thought to be important in tissue healing, and is resistant to degradation by plasmin.

In vivo testing has confirmed the stimulation of defect healing with use of the hydrogel composite, with induction of a hypercellular and hypervascular scar in an ACL non-union model only three weeks after implantation of the scaffold, as well as a return of biomechanical strength of the repair site six weeks after implantation of the hydrogel.

Our preliminary studies on the biomechanical strength of the treated and untreated defects also show significant increases in tissue strength with treatment with our scaffold.

Stimulation of tissue healing and regeneration, rather than resection and replacement, will likely be one of the major advances in orthopedic surgery over the next decade. Definition of the correct cellular environment and scaffold to enhance tissue regeneration and healing is a critical part of this process.

This project allows us to further study the effect of cell environment on both histologic and mechanical tissue healing in an established in vivo model, and is a critical step in our overall work in understanding the cellular processes involved in intra-articular tissue regeneration.

Current data suggests these approaches will be valuable for additional intra-articular tissues as well, as ACL, including cartilage, meniscus and tendon.

The Technology
We have developed an arthroscopic delivery system, manufactured by TNCO, designed to enhance the success rate of primary repair of ACL and meniscal tears. Use of the current device and biologic has the following advantages over the current method of treatment:
  • it is arthroscopic and thus minimally invasive for patients,
  • it enhances the surgeon's ability to preserve native tissue (including the intrinsic fibroblasts, ECM proteins, vascularity and nerve supply),
  • it avoids the complications of allograft morbidities.

It also has the potential to improve the ease and speed of patient rehabilitation after surgery. We are currently performing pilot studies of this technology in large animal models, and with completion of these studies plan to start early clinical trials in patients.

Inititial Prototype
Initial Protoype
For more information about this collaboration please see the following article.
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