التفاصيل البيبلوغرافية
| العنوان: |
Allogeneic ABCB5+ Mesenchymal Stem Cells for Treatment-Refractory Chronic Venous Ulcers: A Phase I/IIa Clinical Trial |
| المؤلفون: |
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 |
| المصدر: |
JID Innovations, Vol 2, Iss 1, Pp 100067- (2022) |
| بيانات النشر: |
Elsevier, 2022. |
| سنة النشر: |
2022 |
| المجموعة: |
LCC:Dermatology |
| مصطلحات موضوعية: |
Dermatology, RL1-803 |
| الوصف: |
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. |
| نوع الوثيقة: |
article |
| وصف الملف: |
electronic resource |
| اللغة: |
English |
| تدمد: |
2667-0267 |
| Relation: |
http://www.sciencedirect.com/science/article/pii/S2667026721000680; https://doaj.org/toc/2667-0267 |
| DOI: |
10.1016/j.xjidi.2021.100067 |
| URL الوصول: |
https://doaj.org/article/30269062a0c04e579251c083a6768869 |
| رقم الانضمام: |
edsdoj.30269062a0c04e579251c083a6768869 |
| قاعدة البيانات: |
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