VENDAJE™ AC

Dehydrated human amniotic membrane allograft with chorion

VENDAJE™️ AC is a dehydrated human amnion/chorion membrane allograft with numerous clinical applications. Derived from the placenta, VENDAJE™️ AC retains the full spectrum of growth factors, cytokines, and bioactive extracellular matrix (ECM) scaffolding that support fetal development and regulate fetomaternal immunity. VENDAJE™️ AC also includes Wharton's jelly, which is a connective tissue in the umbilical cord that’s rich in collagen, hyaluronic acid, and growth factors.

VENDAJE™️ AC allografts are aseptically processed and terminally sterilized, making them suitable for topical and intra-operative applications, and they have an ambient shelf life of 3-years. The minimally manipulated, dehydrated membrane provides a natural scaffold for cellular ingrowth with minimal scarring. VENDAJE™️ AC is anti-inflammatory, anti-microbial, and a natural pathogen barrier, resulting in improved clinical outcomes and patient satisfaction.

VENDAJE™ AC is available in 1x1cm, 2x2cm, 2x4cm, 4x4cm, 4x6cm, 4x8cm, and 6x6cm sizes.

The amniotic sac is the inner lining of the placenta, and it supports the fetus throughout development, so it needs to be strong, flexible, and adaptable. It’s made of two distinct but conjoined membranes, the amnion and chorion. The structural integrity of the amniotic and chorionic membranes is due to a complex, bioactive ECM that is composed of collagens, fibronectin, laminin, and proteoglycans, which are integral to tissue regeneration and wound healing1. The ECM also has a high concentration of hyaluronic acid, which promotes non-fibrotic healing and minimizes scarring2.

Multipotent amniotic epithelial and mesenchymal stem cells secrete a broad array of growth factors that support fetal development, including epidermal growth factor (EGF), basic fibroblast growth factor (bFGF), keratinocyte growth factor (KGF), transforming growth factors alpha and beta (TGF‐α and TGF‐β), and nerve growth factor (NGF)3. Used therapeutically, these compounds have powerful healing capabilities even in chronic conditions.

The amniotic and chorionic membranes produce a number of paracrine-acting immunosuppressive cytokines, including interleukins 4 and 10 (IL-4 and IL-10) and prostaglandin E2 (PGE2), which inhibit activation and proliferation of CD4+ and CD8+ T cells and B cells and suppress differentiation of monocytes to antigen-presenting dendritic cells4. Amniotic immunosuppressors also upregulate anti-inflammatory M2 macrophage activation5 and block the release of pro-inflammatory IFN-γ from cytotoxic natural killer (NK) cells6.

The amniotic membranes have a long history in regenerative medicine7, and new applications are identified regularly. Amniotic allografts promote re-epithelialization while minimizing inflammation, making them ideal topical treatments for burns8 (even in pediatric populations9), pressure ulcers10, and other dermal wounds. Chronic conditions like diabetic ulcers are also improved with amniotic allografts11.

Other common applications for amniotic allografts include reconstruction of conjunctival and ocular surfaces12, tendon repair13, osteoarthritis14, and neuropathy15. In addition, amniotic tissue contains numerous growth factors and proteins that have been shown to improve bone healing16-17, regenerate nervous tissue15, and prevent fibrogenesis. Dermatologists are using amniotic allografts to restore a youthful appearance18. Ongoing clinical studies are evaluating amniotic tissue allografts for the prevention and treatment of fibrotic diseases that affect the liver19, lungs20, nervous system21-22, and to repair infarcted myocardial tissue23.

VENDAJE™ AC Key Points

  • Bonds with wounds by forming fibrin-elastin at the wound-dressing interface
  • Acts as a vapor barrier, preventing fluid loss from excessive evaporation from the wound surface
  • Designed for application directly to acute and chronic wounds
  • Adheres naturally via hydrostatic tension
  • No blood typing or donor matching required
  • No orientation issues, can be applied on either side
  • Contains full spectrum of growth factors
  • Biocompatible scaffold with extracellular matrix
  • No Immune Rejection
  • Moderate levels of fibronectin and laminin
  • Anti-fibrotic and anti-adhesion barrier
  • High tensile strength

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References
1. Olczyk, P., L. Mencner, and K. Komosinska-Vassev, The role of the extracellular matrix components in cutaneous wound healing. Biomed Res Int, 2014. 2014: p. 747584.
2. Nyman, E., et al., Hyaluronic acid, an important factor in the wound healing properties of amniotic fluid: in vitro studies of re-epithelialisation in human skin wounds. J Plast Surg Hand Surg, 2013. 47(2): p. 89-92.
3. Koob, T.J., et al., Properties of dehydrated human amnion/chorion composite grafts: Implications for wound repair and soft tissue regeneration. J Biomed Mater Res B Appl Biomater, 2014. 102(6): p. 1353-62.
4. Li, H., et al., Immunosuppressive factors secreted by human amniotic epithelial cells. Invest Ophthalmol Vis Sci, 2005. 46(3): p. 900-7.
5. Banas, R., et al., Amnion-derived multipotent progenitor cells inhibit blood monocyte differentiation into mature dendritic cells. Cell Transplant, 2014. 23(9): p. 1111-25.
6. Chatterjee, D., et al., Role of gamma-secretase in human umbilical-cord derived mesenchymal stem cell mediated suppression of NK cell cytotoxicity. Cell Commun Signal, 2014. 12: p. 63.
7. Silini, A.R., et al., The Long Path of Human Placenta, and Its Derivatives, in Regenerative Medicine. Frontiers in bioengineering and biotechnology, 2015. 3: p. 162-162.
8. Shpichka, A., et al., Skin tissue regeneration for burn injury. Stem cell research & therapy, 2019. 10(1): p. 94-94.
9. Puyana, S., et al., The Use of Dehydrated Human Amniotic/Chorionic Membrane Skin Substitute in the Treatment of Pediatric Facial Burn. J Craniofac Surg, 2019. 30(8): p. 2551-2554.
10. Dehghani, M., et al., Grafting with Cryopreserved Amniotic Membrane versus Conservative Wound Care in Treatment of Pressure Ulcers: A Randomized Clinical Trial. Bulletin of emergency and trauma, 2017. 5(4): p. 249-258.
11. Haugh, A.M., et al., Amnion Membrane in Diabetic Foot Wounds: A Meta-analysis. Plastic and reconstructive surgery. Global open, 2017. 5(4): p. e1302-e1302.
12. Liu, J., et al., Update on amniotic membrane transplantation. Expert Rev Ophthalmol, 2010. 5(5): p. 645-661.
13. Ang, J., C.D. Liou, and H.P. Schneider, The Role of Placental Membrane Allografts in the Surgical Treatment of Tendinopathies. Clin Podiatr Med Surg, 2018. 35(3): p. 311-321.
14. Vines, J.B., et al., Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. J Knee Surg, 2016. 29(6): p. 443-50.
15. Li, Y., et al., Amniotic mesenchymal stem cells display neurovascular tropism and aid in the recovery of injured peripheral nerves. J Cell Mol Med, 2014. 18(6): p. 1028-34.
16. Karacal, N., et al., Effect of human amniotic fluid on bone healing. J Surg Res, 2005. 129(2): p. 283-7.
17. Nunley, P.D., et al., Preliminary Results of Bioactive Amniotic Suspension with Allograft for Achieving One and Two-Level Lumbar Interbody Fusion. Int J Spine Surg, 2016. 10: p. 12.
18. Davis, A. and A. Augenstein, Amniotic Allograft Implantation for Midface Aging Correction: A Retrospective Comparative Study with Platelet-Rich Plasma. Aesthetic Plast Surg, 2019. 43(5): p. 1345-1352.
19. Andrewartha, N. and G. Yeoh, Human Amnion Epithelial Cell Therapy for Chronic Liver Disease. Stem Cells Int, 2019. 2019: p. 8106482.
20. Azargoon, A. and B. Negahdari, Lung regeneration using amniotic fluid mesenchymal stem cells. Artif Cells Nanomed Biotechnol, 2018. 46(3): p. 447-451.
21. Bolat, E., et al., Investigation of efficacy of mitomycin-C, sodium hyaluronate and human amniotic fluid in preventing epidural fibrosis and adhesion using a rat laminectomy model. Asian Spine J, 2013. 7(4): p. 253-9.
22. Ozgenel, G.Y. and G. Filiz, Effects of human amniotic fluid on peripheral nerve scarring and regeneration in rats. J Neurosurg, 2003. 98(2): p. 371-7.
23. Henry, J.J.D., et al., Development of Injectable Amniotic Membrane Matrix for Postmyocardial Infarction Tissue Repair. Adv Healthc Mater, 2020. 9(2): p. e1900544.