Human Allografts Improve Healing Outcomes In Chronic Wounds
Robert G. Audet1, Robert B. Diller2, Dominic Dominguez1, Tatum A. Bardsley1, Robert S. Kellar1.
1Axolotl Biologix, Inc, Flagstaff, AZ, USA, 2Axolotl Biologix, Inc, Phoenix, AZ, USA.
Background: Axolotl Biologix is a regenerative medicine company producing allograft products from the human amnion using the BioSym™ process. Axolotl Ambient™, a conditioned media rich in cytokines and growth factors is derived from human amniotic epithelial and amniotic mesenchymal stromal cells. Axolotl DualGraft™ is a dehydrated, acellular human amniotic membrane that promotes soft tissue repair by serving as a barrier and extracellular matrix scaffold and providing a source of growth factors. Both allografts were used with difficult-to-close or intractable wounds to assess their efficacy in facilitating wound closure and healing. Methods: Axolotl Ambient™ was injected into the wound margins and Axolotl DualGraft™ was placed within the exposed wound bed. Wounds were bandaged per standard of care and imaged regularly to monitor wound healing progression. ELISAs were used to measure growth factors promoting angiogenesis (FGF-b, ANG-2, and VEGF) and cellular proliferation and ECM growth (EGF and TGF-β). Biological activity of the allografts was measured by in vitro cell-based assays, including endothelial cell tube forming assays and cellular proliferation assays. Results: Compared to controls, assay data showed an increase in endothelial cell mesh networks with the allografts and an increase in cellular proliferation. Conclusions: Clinical application of the allografts in intractable wounds have yielded dramatic improvement in wound closure and reepithelialization. In vitro assays showed increased mesh networks and cellular number which correlated with clinical observations, suggesting Axolotl Ambient™ and Axolotl DualGraft™ facilitate closure and healing of intractable dermal wounds via increased angiogenesis and cellular proliferation. Longitudinal clinical studies are ongoing, concurrent with additional benchtop studies to further elucidate clinically observed wound healing.
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