Amarantus Bioscience Holdings, Inc. · OTC:AMBS
Amarantus Bioscience — Tissue Products for Emergency Preparedness Symposium – May 2015
23 slides from Amarantus Bioscience's conference presentation, Oct 8, 2015
Slide 1: Experience with an Autologous Bilayered Engineered Skin Replacement
Tissue Products for Emergency Preparedness Symposium – May 2015 OASH Office of the Assistant Secretary for Health Experience with an Autologous Bilayered Engineered Skin Replacement Richard J. Kagan, MD, FACS Chief of Staff, Emeritus Shriners Hospitals for Children, Cincinnati Consultant, Lonza, Inc
Slide 2: Operative Strategy for the Closure of Full-thickness Burns
Operative Strategy for the Closure of Full-thickness Burns Small < 20% TBSA Medium 20-35% TBSA Excise (1-2 stages) Large 35-70% TBSA Extensive > 70% TBSA Skin Autograft (Sheet vs. Mesh) Excise (Multiple stages) Use Available Autograft Cover Remaining Wound With Allograft and/or Integra Thin Skin Aut
Slide 3: Important Considerations in Selecting a Skin Substitute or Skin Replacement
Tissue Products for Emergency Preparedness Symposium – May 2015 Important Considerations in Selecting a Skin Substitute or Skin Replacement • Permanency • Rate of engraftment • Need for reapplications • Cost-effectiveness 3
Slide 4: Cost of Common Skin Substitutes/Replacements
Cost of Common Skin Substitutes/Replacements Product Permanency Cost/100 cm2 Biobrane® No $ 100 Allograft No/Yes $ 160 Alloderm® Yes $ 912 Integra® Yes $1,368 Epicel® Yes $2,440 Apligraf® No $2,310 Permaderm® (ESS) Yes $3,200*
Slide 5: Options for Permanent Wound Closure
Tissue Products for Emergency Preparedness Symposium – May 2015 Options for Permanent Wound Closure • Autologous skin grafts • Engineered skin component grafts – Acellular dermal replacements – Tissue-cultured autologous bilayered skin grafts – Tissue-cultured autologous epithelial skin grafts – Tis
Slide 6: Engineered Skin Substitute (Replacement)
Tissue Products for Emergency Preparedness Symposium ¡V May 2015 Engineered Skin Substitute (Replacement) ¡E Composition: bilayered human skin containing autologous epidermal keratinocytes & dermal fibroblasts ¡E Approved investigational uses „« Extensive full-thickness burns „« Burn reconstruction
Slide 7: 2015
Tissue Products for Emergency Preparedness Symposium – May 2015
Slide 8: Engineered Skin Substitutes
Tissue Products for Emergency Preparedness Symposium – May 2015 8 0.1 mm e d • biopolymer (collagen sponge) • partially stratified epithelium (e) attached to a dermal substitute (d), avascular, no appendages, 0.3-0.5 mm thick • ~ 30 or 120 cm2 in area Engineered Skin Substitutes
Slide 9: Operative Procedures
Tissue Products for Emergency Preparedness Symposium – May 2015 9 Removal of silastic Graft bed prepared Operative Procedures • Integra had: - silastic removed - irrigation with nutrients and antimicrobials • Graft bed had: - vascularized Integra® - no epithelium - low microbial load
Slide 10: Surgical Methods
Tissue Products for Emergency Preparedness Symposium – May 2015 10 Surgical Methods • ESS - ~ 6 X 6 cm, or 12 X 12 cm - covered with N-Terface™ - attached with staples • Dressings - fine mesh gauze - coarse gauze - irrigated with antimicrobials - stretched Spandex™
Slide 11: Clinical Results
Tissue Products for Emergency Preparedness Symposium – May 2015 11 POD 7 POD 28 Clinical Results • POD 7: - wound is closed - lotion and gauze - therapy can begin • POD 28, skin had: - smooth surface - minimal scar - hypopigmentation - compression garments
Slide 12: Patient Demographics (n=54)
Tissue Products for Emergency Preparedness Symposium – May 2015 Patient Demographics (n=54) 12 Boyce et al., J Burn Care Res, 2006; J Trauma, 2006.
Slide 13: Results: Engraftment
Tissue Products for Emergency Preparedness Symposium – May 2015 Results Engraftment Closed:donor areas ESS AG % Area Closed at POD 14 0 20 40 60 80 100 120 79.5 95.7 * Closed : Donor Areas at POD 28 0 20 40 60 80 100 * 4 61.5 * , p < 0.01 ESS AG Boyce et al., J Burn Care Res, 2006; J Trauma, 2006.
Slide 14: Outcome at ~1 Year
Tissue Products for Emergency Preparedness Symposium – May 2015 OASH Office of the Assistant Secretary for Health Outcome at ~ 1 Year CSS CSS CSS CSS AG CSS AG
Slide 15: Engineered Skin Substitutes Combined with Integra
Tissue Products for Emergency Preparedness Symposium – May 2015 Engineered Skin Substitutes Combined with Integra® • skin is soft, smooth & strong • usually no regrafting • pigmentation is deficient AG CSS Boyce et al, JBCR 20:453, 1999.
Slide 16: Results: Vancouver Score
Tissue Products for Emergency Preparedness Symposium – May 2015 Results: Vancouver Score 16 POD range14-2728-6263-182183-364>364Vancouver Score012345CSSSSAG****, p<0.05
Slide 17: Congenital Nevus
5 months post CSS Congenital Nevus pre-CSS
Slide 18: % yrs post CSS yrs post CSS
8 % yrs post CSS 13 yrs post CSS ~< ley
Slide 19: FDA Actions
Tissue Products for Emergency Preparedness Symposium – May 2015 FDA Actions • 2006: inspection and numerous citations (Form 483) • 2007: Integrity Hold Letter issued to UC as sponsor 19
Slide 20: FDA Actions
Tissue Products for Emergency Preparedness Symposium – May 2015 FDA Actions • 2006: inspection and numerous citations (form 483) • 2007: Integrity Hold Letter issued to UC as sponsor • 2007-2010: 16 subjects enrolled by Compassionate Use permission • 2010: Enrollment closed by UC • 2014: Integrity H
Slide 21: Patient with 81% TBSA full-thickness burns
Tissue Products for Emergency Preparedness Symposium – May 2015 17 year old 81% TBSA full-thickness burns
Slide 22: Demographic Data of the Patient Population
Tissue Products for Emergency Preparedness Symposium – May 2015 22 Demographic Data of the Patient Population 16 patients enrolled: 2007-2010 15 treated, 1 expired pretreatment This study was performed under an Investigative Device Exemption regulated by the US FDA.
Slide 23: LA50 for Burn Injuries: 1940-2007
Shriners Hospitals for Children • Shriners Burns Hospital • Cincinnati, Ohio LA50 for Burn Injuries: 1940-2007 0 10 20 30 40 50 60 70 80 90 100 Percent TBSA Burn Associated with a 50% Mortality 1940 1950 1960 1970 1980 1993 2005 Aggressive nutrition Broad spectrum antibiotics Aggressive excision & t