Safety evaluation of bi‐layered allogenic keratinocyte and fibroblast skin substitute for diabetic foot ulcers—<scp>SAFESKIN</scp>‐<scp>DFU</scp>: A Phase <scp>1</scp> clinical trial-Reference-Cited by-同舟云学术

Safety evaluation of bi‐layered allogenic keratinocyte and fibroblast skin substitute for diabetic foot ulcers—SAFESKIN‐DFU: A Phase 1 clinical trial

Published:2024-08-19 Issue: Volume: Page:
ISSN:1462-8902
Container-title:Diabetes, Obesity and Metabolism
language:en
Short-container-title:Diabetes Obesity Metabolism

Author:

Farzanbakhsh Shayan¹,Amini Mohammad Reza²,Madani Hoda¹,Sadri Bahareh¹^ORCID,Hassani Seyedeh Nafiseh³,Fallah Nasrin⁴,Samadian Azam⁴,Aghdami Raheleh⁴,Khalajasadi Zahra⁴,Baharvand Hossein³,Vosough Massoud¹^ORCID,Hajizadeh‐Saffar Ensiyeh¹⁴

Affiliation:

1. Department of Regenerative Medicine Cell Science Research Centre, Royan Institute for Stem Cell Biology and Technology, ACECR Tehran Iran

2. Diabetes Research Centre, Endocrinology and Metabolism Clinical Sciences Institute Tehran University of Medical Sciences Tehran Iran

3. Department of Stem Cells and Developmental Biology Cell Science Research Centre, Royan Institute for Stem Cell Biology and Technology, ACECR Tehran Iran

4. Advanced Therapy Medicinal Product Technology Development Centre (ATMP‐TDC), Cell Science Research Centre, Royan Institute for Stem Cell Biology and Technology, ACECR Tehran Iran

Abstract

AbstractAimTo assess the safety and efficacy of a local skin substitute product in the treatment of chronic diabetic foot ulcers (DFUs).Materials and MethodsFive patients were evaluated over 6 months. Skin substitutes were applied twice at 2‐week intervals. Patients were monitored for any possible adverse effects and wound improvement.ResultsThe results indicated the overall safety of the skin substitute, with only few adverse effects unrelated to this product. Significant reduction in wound size was observed in four patients during the initial 12‐week treatment phase, with complete closure in two patients at 24 weeks.ConclusionsThe application of a bi‐layered allogeneic keratinocyte and fibroblast skin substitute in patients with chronic DFU was safe and associated with favourable wound healing results. Adherence to standard treatment protocols, including optimal offloading, is essential to maximize the likelihood of successful wound healing.

Publisher

Wiley

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