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This is the first approach that uses a native freeze-dried soft tissue allograft as a delivery vehicle for therapeutic genes as opposed to others.
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Summary A large number of therapeutic agents (growth factors and cytokines) have the potential to enhance repair in tendon and ligament allografts. However, our ability to design repair and anti-adhesion adjuvants for tendons is dependent upon developing efficacious delivery protocols of such therapeutic agents. Unfortunately, direct delivery of proteins may be limited due to limited half life and diffusive hindrance. Alternatively, local transfer of genes that express the relevant healing factors may provide a solution to this problem. Unlike biomaterial scaffolds used for therapeutic delivery of biomolecules in which the biomolecule experiences a burst release rendering its effect short-lived and minimal, therapeutic release in the processed soft tissue is slow and sustained since (1) interstitial water in these negatively-charged tissues is physically-bound which increases the retention of the therapeutic and controls its release, and (2) certain matrix molecules (such as small leucine-rich proteoglycans or SLRPs) in tendons and soft tissues are known to sequester growth factors in the extracellular matrix and mediate their signaling thus sustaining and possibly regulating and boosting the therapeutic effects.