2011
DOI: 10.1097/sla.0b013e318210f3bd
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Abstract: Objective The goal of this study was to assess the immunogenicity and antigenicity of StrataGraft skin tissue in a randomized phase I/II clinical trial for the temporary management of full-thickness skin loss. Summary Background Data StrataGraft skin tissue consists of a dermal equivalent containing human dermal fibroblasts and a fully-stratified, biologically active epidermis derived from NIKS cells, a pathogen-free, long-lived, consistent, human keratinocyte progenitor. Methods Traumatic skin wounds ofte… Show more

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Cited by 73 publications
(53 citation statements)
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References 62 publications
(53 reference statements)
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“…No acute inflammatory infiltrate was found in any of the allografted tissues. The data presented 9 show that after placement of NIKS-based BSS for 1 week in full-thickness wounds, normal tissue architecture was maintained with no substantial inflammatory infiltrate seen. These data are suggestive that this BSS did not induce an acute inflammatory response in patients with fullthickness skin loss and is in agreement with clinical experience with other allogeneic products as described above.…”
Section: Allograft Tissues Did Not Induce Acute Inflammatory Infiltramentioning
confidence: 87%
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“…No acute inflammatory infiltrate was found in any of the allografted tissues. The data presented 9 show that after placement of NIKS-based BSS for 1 week in full-thickness wounds, normal tissue architecture was maintained with no substantial inflammatory infiltrate seen. These data are suggestive that this BSS did not induce an acute inflammatory response in patients with fullthickness skin loss and is in agreement with clinical experience with other allogeneic products as described above.…”
Section: Allograft Tissues Did Not Induce Acute Inflammatory Infiltramentioning
confidence: 87%
“…Results of this trial demonstrate that this BSS tissue, a biologically active, fully stratified, temporary wound covering generated using NIKS keratinocytes, was well tolerated and showed no evidence of safety concerns. 8,9 Expression of the host defense peptide, human beta defensin-3, is increased in NIKS-based BSS Due to the increasing importance of HDPs in combating infection and modulating host immune responses, prior to clinical evaluation the expression of human beta defensin-3 (HBD-3) was examined. Quantitative polymerase chain reaction analysis revealed an approximately 8-fold increase in HBD-3 in NIKS-based BSS when compared to skin tissue from either primary human epidermal keratinocytes or the parental keratinocytes from which NIKS arose.…”
Section: Discussion Of Findings and Relevant Literaturementioning
confidence: 99%
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“…Allogeneic skin substitutes generated with NIKS keratinocytes have been evaluated in a Phase I/IIa clinical trial for the temporary management of traumatic skin wounds. 15,16 NIKS-based skin substitutes were found to be comparable to the standard of care of cadaver skin, were well tolerated, and did not elicit acute allogeneic immune responses to NIKS cells in treated patients. No therapy-related adverse events were observed.…”
Section: Target Articlementioning
confidence: 99%
“…22,23 However, clinical findings with BSS therapies suggest that cultured skin tissue is unlikely to be acutely rejected in humans. [24][25][26][27][28] Skin substitutes are gradually replaced by the patient's skin with no excessive inflammation or other signs of acute rejection. [25][26][27][28] Finally, a limitation of all cell-based BSS therapies is the high cost of manufacturing.…”
Section: Experimental Model: Advantages and Limitationsmentioning
confidence: 99%