Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 321

PolarityTE Announces Positive Pilot Study Data of SkinTE as a Treatment for Venous Stasis Leg Ulcers

Posted by fidest press agency su mercoledì, 16 ottobre 2019

PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing and commercializing regenerative tissue products and biomaterials, today announced findings from an open-label, single-arm pilot study, which examined the impact of SkinTE™, a novel human cellular and tissue-based product derived from a patient’s own skin, in closing venous stasis leg ulcers (VLUs) following failure of conventional treatments. The clinical outcomes were reported in a poster presentation, entitled Pilot Study Assessing Novel Autologous Homologous Skin Construct Treatment of Venous Stasis Leg Ulcers, at the Symposium on Advanced Wound Care (SAWC) Fall Meeting, held in Las Vegas, October 12-14, 2019. In addition, the study poster abstract received the highest scores from reviewers in the Case Series/Study Category, the largest category at the conference.
The pilot study included 10 patients with VLUs that remained open after at least one month of conventional treatments. The patients were treated with SkinTE, a first-of-its-kind autologous, homologous human cellular and tissue-based product designed to regenerate full-thickness, functional skin for the repair, reconstruction, and replacement of a patient’s own skin.The study found an 80 percent closure rate of the VLUs within 12 weeks after treatment with SkinTE. In addition, all of the patients’ wounds demonstrated graft take and initial signs of closure, including granulation and progressive epithelialization, shortly after a single treatment with SkinTE. One treated VLU, which had previously been deemed closed, had reopened prior to the 2-week durability visit as a result of external factors unrelated to the SkinTE procedure. Further, another VLU did not close within 12 weeks, which was the largest in the study (12.2cm2) and had remained open for several months prior to treatment with SkinTE after previously failed treatment with a split-thickness skin graft; this VLU closed within 13.5 weeks post application of SkinTE.

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