Allogeneic ABCB5+ Mesenchymal Stem Cells for Treatment-Refractory Chronic Venous Ulcers: A Phase I/IIa Clinical Trial

Allogeneic ABCB5+ Mesenchymal Stem Cells for Treatment-Refractory Chronic Venous Ulcers: A Phase I/IIa Clinical Trial

A significant number of chronic venous ulcers (CVUs) fail to heal despite guideline-conform standards of care. Skin-derived ABCB5+ mesenchymal stem cells can dampen the sustained IL-1β‒driven inflammation present in chronic wounds. On the basis of their wound healing‒facilitating effects in a mouse...

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Autores principales: Andreas Kerstan, Kathrin Dieter, Elke Niebergall-Roth, Ann-Kathrin Dachtler, Korinna Kraft, Markus Stücker, Georg Daeschlein, Michael Jünger, Tobias Görge, Ulrich Meyer-Pannwitt, Cornelia Erfurt-Berge, Charlotte von Engelhardt, Andreas Klare, Christiane Pfeiffer, Jasmina Esterlechner, Hannes M. Schröder, Martin Gasser, Ana M. Waaga-Gasser, Matthias Goebeler, Seda Ballikaya, Samar Sadeghi, George F. Murphy, Dennis P. Orgill, Natasha Y. Frank, Christoph Ganss, Karin Scharffetter-Kochanek, Markus H. Frank, Mark A. Kluth
Formato: article
Lenguaje:EN
Publicado: Elsevier 2022
Materias:
Dermatology
RL1-803
Acceso en línea:https://doaj.org/article/30269062a0c04e579251c083a6768869
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Sumario:A significant number of chronic venous ulcers (CVUs) fail to heal despite guideline-conform standards of care. Skin-derived ABCB5+ mesenchymal stem cells can dampen the sustained IL-1β‒driven inflammation present in chronic wounds. On the basis of their wound healing‒facilitating effects in a mouse CVU model and an autologous first-in-human study, ABCB5+ mesenchymal stem cells have emerged as a potential candidate for cell-based advanced therapy of nonhealing CVUs. In this interventional, multicenter, single-arm, phase I/IIa clinical trial, subjects whose CVUs had emerged as standard therapy resistant received one or two topical applications of 1 × 106 allogeneic ABCB5+ mesenchymal stem cells per cm2 wound area, in addition to standard treatment. Of 83 treatment-emergent adverse events, only three were judged related to the cell product; they were mild or moderate and recovered without sequelae. Wound size markedly decreased from baseline to week 12, resulting in a median wound size reduction of 76% (full analysis set, n = 31), 78% (per-protocol set, n = 27), and 87% (subset of responders, n = 21). In conclusion, the study treatment was well-tolerated and safe. The treatment elicited a profound wound size reduction within 12 weeks, identifying ABCB5+ mesenchymal stem cells as a potential candidate for adjunctive therapy of otherwise incurable CVUs. These results justify the conduct of a larger, randomized, controlled trial to confirm clinical efficacy.

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