title: Characterization of a Cryopreserved Split-Thickness Human Skin Allograft-TheraSkin.
abstract: OBJECTIVE
  The purpose of this study was to examine the characteristics of a cryopreserved split-thickness skin allograft produced from donated human skin and compare it with fresh, unprocessed human split-thickness skin.
  
  
  BACKGROUND
  Cutaneous wound healing is a complex and organized process, where the body re-establishes the integrity of the injured tissue. However, chronic wounds, such as diabetic or venous stasis ulcers, are difficult to manage and often require advanced biologics to facilitate healing. An ideal wound care product is able to directly influence wound healing by introducing biocompatible extracellular matrices, growth factors, and viable cells to the wound bed.
  
  
  METHODS
  TheraSkin (processed by LifeNet Health, Virginia Beach, Virginia, and distributed by Soluble Systems, Newport News, Virginia) is a minimally manipulated, cryopreserved split-thickness human skin allograft, which contains natural extracellular matrices, native growth factors, and viable cells. The authors characterized TheraSkin in terms of the collagen and growth factor composition using ELISA, percentage of apoptotic cells using TUNEL analysis, and cellular viability using alamarBlue assay (Thermo Fisher Scientific, Waltham, Massachusetts), and compared these characteristics with fresh, unprocessed human split-thickness skin.
  
  
  RESULTS
  It was found that the amount of the type I and type III collagen, as well as the ratio of type I to type III collagen in TheraSkin, is equivalent to fresh unprocessed human split-thickness skin. Similar quantities of vascular endothelial growth factor, insulinlike growth factor 1, fibroblast growth factor 2, and transforming growth factor β1 were detected in TheraSkin and fresh human skin. The average percent of apoptotic cells was 34.3% and 3.1% for TheraSkin and fresh skin, respectively.
  
  
  CONCLUSIONS
  Cellular viability was demonstrated in both TheraSkin and fresh skin.
authors.affiliation: Adam Landsman, DPM, PhD, is Assistant Professor of Surgery, Harvard School of Medicine; Chief, Division of Podiatric Surgery, Cambridge Health Alliance, Cambridge, Massachusetts; and Consultant, LifeNet Health, Virginia Beach, Virginia. Eran Rosines, PhD, is a Staff Scientist; Amanda Houck, MS, is a Senior Research Associate; Angela Murchison, BS, is a Senior Research Technician; Alyce Jones, PhD, is Director of Cardiovascular Product Development; Xiaofei Qin, MD, PhD, is a Senior Scientist; and Silvia Chen, MBA, PhD, is a Scientific Officer, LifeNet Health. Arnold R. Landsman, DPM, is the Past President of the Virginia Podiatric Medical Association. Dr Adam Landsman has disclosed that he is a board member of LifeNet Health and a consultant to Soluble Systems. Dr Arnold Landsman has disclosed that he received payment from Soluble Systems for writing/reviewing the manuscript. Dr Rosines, Ms Houck, Ms Murchison, Dr Qin, Dr Jones, and Dr Chen have disclosed they have no financial relationships related to this article other than their current or previous employment at LifeNet Health.
authors.forename: Adam
authors.initials: A
authors.lastname: Landsman
authors.forename: Eran
authors.initials: E
authors.lastname: Rosines
authors.forename: Amanda
authors.initials: A
authors.lastname: Houck
authors.forename: Angela
authors.initials: A
authors.lastname: Murchison
authors.forename: Alyce
authors.initials: A
authors.lastname: Jones
authors.forename: Xiaofei
authors.initials: X
authors.lastname: Qin
authors.forename: Silvia
authors.initials: S
authors.lastname: Chen
authors.forename: Arnold R
authors.initials: AR
authors.lastname: Landsman
mesh_terms: D001672:Biocompatible Materials; D015925:Cryopreservation / Q000379:methods*; D006801:Humans; D016038:Skin Transplantation / Q000379:methods*; D017768:Skin, Artificial; D013524:Surgical Flaps; D014182:Transplantation, Autologous; D014945:Wound Healing; D014947:Wounds and Injuries / Q000628:therapy*
chemical_list: D001672:Biocompatible Materials