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Allogeneic ABCB5+ mesenchymal stem cells for treatment-refractory chronic venous ulcers: a phase I/IIa clinical trial.


ABSTRACT: A significant number of chronic venous ulcers (CVUs) fail to heal despite of guideline-conform standard of care. Skin-derived ABCB5+ mesenchymal stem cells (MSCs) can dampen the sustained IL-1β-driven inflammation present in chronic wounds. Based on their wound healing-facilitating effects in a mouse CVU model and an autologous first-in-human study, ABCB5+ MSCs have emerged as a potential candidate for cell-based advanced therapy of non-healing CVUs. In the present interventional, multicenter, single-arm, phase I/IIa clinical trial, subjects whose CVU had emerged as standard therapy-resistant received one or two topical applications of 1×106 allogeneic ABCB5+ MSCs/cm2 wound area in addition to standard treatment. Out 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+ MSCs 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.

SUBMITTER: Kerstan A 

PROVIDER: S-EPMC8635035 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Allogeneic ABCB5<sup>+</sup> mesenchymal stem cells for treatment-refractory chronic venous ulcers: a phase I/IIa clinical trial.

Kerstan Andreas A   Dieter Kathrin K   Niebergall-Roth Elke E   Dachtler Ann-Kathrin AK   Kraft Korinna K   Stücker Markus M   Daeschlein Georg G   Jünger Michael M   Görge Tobias T   Meyer-Pannwitt Ulrich U   Erfurt-Berge Cornelia C   von Engelhardt Charlotte C   Klare Andreas A   Pfeiffer Christiane C   Esterlechner Jasmina J   Schröder Hannes M HM   Gasser Martin M   Waaga-Gasser Ana M AM   Goebeler Matthias M   Ballikaya Seda S   Sadeghi Samar S   Murphy George F GF   Orgill Dennis P DP   Frank Natasha Y NY   Ganss Christoph C   Scharffetter-Kochanek Karin K   Frank Markus H MH   Kluth Mark A MA  

JID innovations : skin science from molecules to population health 20211025 1


A significant number of chronic venous ulcers (CVUs) fail to heal despite of guideline-conform standard of care. Skin-derived ABCB5<sup>+</sup> mesenchymal stem cells (MSCs) can dampen the sustained IL-1β-driven inflammation present in chronic wounds. Based on their wound healing-facilitating effects in a mouse CVU model and an autologous first-in-human study, ABCB5<sup>+</sup> MSCs have emerged as a potential candidate for cell-based advanced therapy of non-healing CVUs. In the present interven  ...[more]

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