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Matridex Dermal Filler presentationm to FACE Conference 2005 by Dr. Patrick Treacy


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Presentation to F.A.C.E. Conference in 2005 by Dr. Patrick Treacy about Matridex Dermal Filler

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Matridex Dermal Filler presentationm to FACE Conference 2005 by Dr. Patrick Treacy

  1. 1. Matrix Engineering A New Concept of Treatment for Skin Rejuvenation Dr Patrick J. Treacy Ailesbury Clinic Dublin
  2. 2. MEDICAL DISCLOSURE: <ul><li>Dr. Patrick J. Treacy is a Cosmetic Doctor registered in UK and Ireland </li></ul><ul><li>I have previously been registered in United States, Australia, New Zealand and South Africa. </li></ul><ul><li>I have no financial interest or stock in BIoPolymer GmbH & Co KG </li></ul><ul><li>I receive no additional remuneration for stock bought by you after attendance at this lecture . </li></ul>
  3. 3.
  4. 4. Matrix Engineering <ul><li>Any new tissue formation such as collagenesis in the dermal compartment of the skin is dependant on many different factors: </li></ul><ul><li>Cells, Cytokines and Extra Cellular Matrix (ECM ). </li></ul><ul><li>The verification of new collagen after a special treatment is demonstrated by High Frequency Echo Sounder as a non-invasive instrument for clinical research. </li></ul>
  5. 5. Cells Cytokines Molecular Dermal Biology Extra Cellular Matrix ( ECM )
  6. 6. Methods and Systematics of Dermal Matrix Engineering Stimulation Collagenesis Microbeads New tissue formation Collagen type I Substitution of Hyaluronic acid
  7. 7. Treatment INTRADERMAL Wrinkles, folds, lip augmentation, lip contour, glabella, naso-labial, fine lines You can use the same product only changing the needle! 22
  8. 8. Matrix Engineering = Augmentation + Regeneration <ul><li>Immediate excellent augmentation of wrinkles and folds </li></ul><ul><li>because of the HylanGel Copolymer </li></ul><ul><li>(RHAI technique). </li></ul><ul><li>Evidence that the positively charged microbeads leads to the creation of new collagen and for a regeneration of the dermis. </li></ul>
  9. 9. The RHAI – technique  <ul><li>By cross-linking sodium hyaluronate a R eticulated H yaluronic A cid I mplant ( RHAI ) is designed. </li></ul><ul><li>In combination with naturally hyaluronic acid and hypromellose a viscoelastic co-polymer is created for biomedical matrix engineering. </li></ul>
  10. 10. Essentials required for the size and texture of particulate material <ul><li>Spherical microspheres or microbeads </li></ul><ul><li>Minimum diameter should be 40 µ </li></ul><ul><li>Smooth, homogeneous surface </li></ul><ul><li>Liquid biocompatible medium </li></ul>
  11. 11. Interaction of cells/tissue with microparticles <ul><li>Macrophage interaction with the biomaterial </li></ul><ul><li>Leads to acute and chronic inflammation </li></ul><ul><li>Results in formation of a fibrous capsule </li></ul><ul><li>Leads to new collagen formation </li></ul>
  12. 12. Interaction of cells/tissue with microparticles <ul><li>These effects are related to </li></ul><ul><li>Surface S mooth </li></ul><ul><li>Size 40 to 150 µm </li></ul><ul><li>Shape S pherical </li></ul><ul><li>Structure B iocompatible </li></ul><ul><li>Carrier L iquid medium </li></ul>
  13. 13. Different Shape and Surface structure of microparticles <ul><li>Irregular shape + </li></ul><ul><li>Rough surface structure </li></ul><ul><li>resulted in: </li></ul><ul><li>Foreign body reaction </li></ul><ul><li>Regular shape+ </li></ul><ul><li>Smooth surface </li></ul><ul><li>resulted in: </li></ul><ul><li>Fibrous tissue with </li></ul><ul><li>neocollagenesis </li></ul>
  14. 14. Migration of particles in the dermal compartment <ul><li>The critical particle size to avoid the phenomenon of migration is 80 to 120 µm </li></ul><ul><li>The extracellular migration caused by mechanical forces (muscle movement, gravity) is called dislocation </li></ul>
  15. 15. Types of Microparticles <ul><li>Permanent </li></ul><ul><li>Polymethylmethacrylate </li></ul><ul><li>Polyvinylhydroxid </li></ul><ul><li>Biodegradable </li></ul><ul><li>Dextranomere </li></ul><ul><li>Hylan Gel particle (xHA) </li></ul>
  16. 16. Matrix Engineering with Matridex <ul><li>Matridex is a new resorbable gel-suspension </li></ul><ul><li>for the treatment of skin defects (wrinkles).In comparison to all other fillers, it works with two effects: </li></ul><ul><li>Replacement of lost hayluronic acid ( augmentation ) </li></ul><ul><li>New formation of collagenous tissue </li></ul><ul><li>( regeneration ) </li></ul>
  17. 17. Composition <ul><li>1 ml Matridex contains: </li></ul><ul><li>Hyaluronic acid 25 mg </li></ul><ul><li>Hylan Gel 25 mg </li></ul><ul><li>Hypromellos 15 mg </li></ul><ul><li>DEAE Sephadex 25 mg </li></ul><ul><li>CE 1275 </li></ul>
  18. 18. Hylan Gel <ul><li>Crosslinked hyaluronic acid </li></ul><ul><li>Biocompatible </li></ul><ul><li>Non-tissue reactive </li></ul><ul><li>Non-antigenic </li></ul><ul><li>High hydration level </li></ul><ul><li>Water insoluble </li></ul><ul><li>Hyaluron, its Crosslinked Derivates – Hylan – and their Medical Application, </li></ul><ul><li>Balazs, Leshchiner, 1989 </li></ul><ul><li>Hylan Gel Biomaterial: Dermal and immunologic compatibility, </li></ul><ul><li>Larsen,Pollack,Balazs, 1993 </li></ul><ul><li>In vitro Cytotoxicity Report </li></ul><ul><li>BioService Project No. 021863, </li></ul><ul><li>2002 </li></ul>
  19. 19. Hypromellose Gel <ul><li>Hydroxypropylmethyl-cellulose (HPMC) </li></ul><ul><li>Biocompatible </li></ul><ul><li>Viscoelastic </li></ul><ul><li>Non-inflammatory </li></ul><ul><li>Chemical and physical properties of Methocel(HPMC) and ist clinical use </li></ul><ul><li>Kamman, 1997 </li></ul><ul><li>Studies of Irritating Action of Methylcellulose </li></ul><ul><li>Fleming, 1959 </li></ul>
  20. 20. Dextranomere <ul><li>Crosslinked Dextran </li></ul><ul><li>Beads </li></ul><ul><li>Spherical </li></ul><ul><li>Size from 80µ - 125µ </li></ul><ul><li>Charged surfaces </li></ul><ul><li>- positively (Matridex/DEAE Sephadex) </li></ul><ul><li>- negatively </li></ul><ul><li>Regulatory support file Sephadex, </li></ul><ul><li>Pharmacia, 2002 </li></ul><ul><li>Regulatory support file DEAE Sephadex, Pharmacia, 2002 </li></ul><ul><li>Regulatory support file CM Sephadex, Pharmacia, 2002 </li></ul>
  21. 21. Dextranomere Tradename: Sephadex <ul><li>Neutral, uncharged beads 40-60 µ leads to migration and granuloma formation </li></ul><ul><li>Negatively charged CM beads stimulating osteogenesis, new bone formation </li></ul><ul><li>Positively charged DEAE beads 80-125 µ no migration, stimulation of collagenesis </li></ul><ul><li>Heel,R.C.,Morton,P.,Brogden,R.N.: „Dextranomere. A review of ist general properties and therapeutic efficacy.“ </li></ul><ul><li>Drugs 1979;18:89-102 </li></ul>
  22. 22. Biocompatibility <ul><li>Biocompatible </li></ul><ul><li>Biodegradable </li></ul><ul><li>Non-sensitization </li></ul><ul><li>Non-cytotoxicity </li></ul><ul><li>Biocompatible viscoelastic gel slurries, their preparation and use </li></ul><ul><li>Leshchiner, 1991 </li></ul><ul><li>Implantation study of Matridex </li></ul><ul><li>Histology report </li></ul><ul><li>ISO 10993-6, 2002 </li></ul><ul><li>Cytotoxicity Assay Matridex </li></ul><ul><li>ISO 10993-5, 2002 </li></ul><ul><li>Sensitization Assay Matridex </li></ul><ul><li>ISO 10993-10, 2002 </li></ul>
  23. 23. Performance <ul><li>Transfer of collagen-stimulating substances </li></ul><ul><li>Transfer of skin hydrating substances </li></ul><ul><li>Transfer of skin regenerating substances </li></ul><ul><li>Enhanced Healing of cutaneous wounds using beads with positively charged surfaces </li></ul><ul><li>Mustoe, 1992 </li></ul><ul><li>Comparative rheological behavior of Hyaluronan from bacterial and animal sources with crosslinked Hyaluronan (Hylan Gel) in aqueous solution </li></ul><ul><li>Milas, 2001 </li></ul><ul><li>Biocompatible visvoelastic slurries, their preparation and use </li></ul><ul><li>Larsen, 1991 </li></ul><ul><li>Implantation Assay Matridex BioService Report No. 021627, 2002 </li></ul>
  25. 26. Injecting technique: When using Matridex or Matridur it is recommanded only injecting in the vermillion border zone. Not from the inner site of the lips ( vestibulum ).
  26. 27. Histology Report 3/52 <ul><li>INTERMATERIAL SPACE </li></ul><ul><li>Small collagen fibre bundles (1 to 10 µm in width) </li></ul><ul><li>Capillaries and fibroblasts </li></ul><ul><li>Macrophages are in close apposition to the beads. </li></ul><ul><li>Sirius red and blue, OM 100 x </li></ul>
  27. 28. Histology Report 1year <ul><li>Extensive fibroblast and collagen exist in the intermaterial space </li></ul><ul><li>Absence of neutrophilic or lymphocytic infiltrate. </li></ul><ul><li>Hematoxylin and eosin, OM 40 x </li></ul><ul><li>Fig. 3 </li></ul>
  28. 29. 1 year after Implantation
  29. 30. No Skin Test Required <ul><li>Non-animal origin of the raw materials in Matridex and Matridur (ex fermentation). </li></ul><ul><li>The basic hyaluronic acid (HA) contains only 0.025 I.U./mg of Endotoxins. </li></ul><ul><li>Highest purity for Hyaluronic acid (HA) </li></ul>
  30. 33. Verification of New Collagen after Treatment High Frequency Echo Sounder Collagenoson DLX MATRIDEX
  31. 34. VERIFICATION OF NEOCOLLAGENESIS Face-Measurements with the Minhorst- Collagenoson before/after Matridex implantation 1 Minute after implantation 3 weeks after implantation NEW COLLAGEN 18 months after implantation NEW COLLAGEN REMAINS
  32. 35. Implantation Implantation <ul><li>intradermal </li></ul><ul><li>bevel of the needle up </li></ul><ul><li>slight molding after implantation </li></ul><ul><li>repetition after 3 weeks is recommanded ( cumulative effect of the stimulation ) </li></ul>
  33. 36. 1 year after Implantation
  34. 37. BioPolymer GmbH & Co.KG Germany E-mail [email_address]