PTE: Two Peer-Reviewed Manuscripts on SkinTE
Jun 1, 2020 13:19:15 GMT
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Post by icemandios on Jun 1, 2020 13:19:15 GMT
PolarityTE—Two Peer-Reviewed Manuscripts Published on SkinTE
References
About SkinTE™
SkinTE is a human cellular and tissue-based product derived from a patient’s own skin (autologous) intended for the repair, reconstruction, replacement or supplementation (i.e., homologous use) of skin tissue and the integumentary system. Aseptic surgical procedures and handling during skin harvest, wound preparation and SkinTE deployment are mandatory.
SALT LAKE CITY
Published Data Includes Pilot Study of SkinTE in Diabetic Foot Ulcers and 15-Patient Case Series
PolarityTE, Inc. (Nasdaq: PTE) reports the recent publication of two peer-reviewed manuscripts involving the application of SkinTE in a pilot study of diabetic foot ulcers and a 15-patient case series evaluating multiple wound types.
A publication reporting results from the Company’s diabetic foot ulcer (DFU) pilot study entitled, “Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers” was published in the International Wound Journal. The primary endpoint of the pilot was the rate of closure at 12 weeks following SkinTE treatment. According to the abstract, “All 11 DFUs demonstrated successful graft take. Ten DFUs closed within 8 weeks. The median time-to-complete closure was 25 days.” PolarityTE is currently conducting a multi-center randomized controlled trial to further evaluate the use of SkinTE in DFUs (NCT03881254).
Another publication entitled, “Autologous Homologous Skin Constructs Allow Safe Closure of Wounds” was published in Plastic and Reconstructive Surgery – Global Open. The retrospective, noncontrolled, 15-patient case series evaluated various wound etiologies, including 5 acute and chronic, 4 acute traumatic, and 6 chronic wounds. According to the publication, “All wounds were closed with a single application of AHSC manufactured from a single tissue harvest.”
Armstrong DG, Orgill DP, Galiano R, et al. Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers. Int Wound J. 2020; 1–10. doi.org/10.1111/iwj.13404 10 ARMSTRONG ET AL.
Mundinger, Gerhard S. MD*,†; Armstrong, David G. DPM, MD, PhD‡; Smith, David J. MD§; Sailon, Alexander M. MD¶; Chatterjee, Abhishek MD, MBA‖; Tamagnini, Greg DPM**; Partridge, Joanna MD††; Baetz, Nicholas PhD‡‡; Labroo, Pratima PhD‡‡; Swanson, Edward W. MD‡‡; Sopko, Nikolai A. MD, PhD‡‡; Granick, Mark S. MD§§ Autologous Homologous Skin Constructs Allow Safe Closure of Wounds, Plastic and Reconstructive Surgery - Global Open: May 18, 2020 - Volume Latest Articles - Issue - doi: 10.1097/GOX.0000000000002840 journals.lww.com/prsgo/Abstract/9000/Autologous_Homologous_Skin_Constructs_Allow_Safe.97393.aspx
SkinTE is a human cellular and tissue-based product derived from a patient’s own skin (autologous) intended for the repair, reconstruction, replacement or supplementation (i.e., homologous use) of skin tissue and the integumentary system. Aseptic surgical procedures and handling during skin harvest, wound preparation and SkinTE deployment are mandatory.