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

Kerstan A, Dieter K, Niebergall-Roth E, Dachtler AK, Kraft K, Stücker M, Daeschlein G, Juenger M, Goerge T, Meyer-Pannwitt U, Erfurt-Berge C, von Engelhardt C, Klare A, Pfeiffer C, Esterlechner J, Schröder H, Gasser M, Waaga-Gasser AM, Goebeler M, Ballikaya S, Sadeghi S, Murphy G, Orgill D, Frank N, Ganss C, Scharffetter-Kochanek K, Frank M, Kluth M (2022)

Publication Type: Journal article

Publication year: 2022

Journal

JID Innovations Elsevier

Book Volume: 2

Journal Issue: 1

DOI: 10.1016/j.xjidi.2021.100067

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.

Authors with CRIS profile

Cornelia Erfurt-Berge Department of Dermatology

Involved external institutions

Harvard University US United States (USA) (US) Universitätsklinikum Ulm DE Germany (DE) RHEACELL GmbH DE Germany (DE) Universitätsklinikum Würzburg DE Germany (DE) TICEBA GmbH DE Germany (DE) Ruhr-Universität Bochum (RUB) DE Germany (DE) Universitätsmedizin Greifswald / Universitätsklinikum Greifswald DE Germany (DE) Universitätsklinikum Münster DE Germany (DE) Klinische Forschung Hamburg GmbH DE Germany (DE) Mare Klinikum DE Germany (DE) Klinische Forschung Schwerin DE Germany (DE) Universität Greifswald DE Germany (DE)

How to cite

APA:

Kerstan, A., Dieter, K., Niebergall-Roth, E., Dachtler, A.-K., Kraft, K., Stücker, M.,... Kluth, M. (2022). Allogeneic ABCB5+ mesenchymal stem cells for treatment-refractory chronic venous ulcers: a phase I/IIa clinical trial. JID Innovations, 2(1). https://doi.org/10.1016/j.xjidi.2021.100067

MLA:

Kerstan, Andreas, et al. "Allogeneic ABCB5+ mesenchymal stem cells for treatment-refractory chronic venous ulcers: a phase I/IIa clinical trial." JID Innovations 2.1 (2022).

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