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other·preclinical research, biomedical research, dermatology, surgery·PMC10407941

In vivo efficacy proof of concept of a large-size bioprinted dermo-epidermal substitute for permanent wound coverage

Frontiers in Bioengineering and Biotechnology · 22 authors, 7 centres

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Human keratinocytes from a 25-year-old donor biopsy were used to manufacture two 40-cm² Poieskin® batches using multimodal bioprinting under GMP-compatible conditions, with histological scoring of 75%±8% and 73%±12%. No significant differences were observed in laser Doppler perfusion, [18F]-FDG MicroPET/CT metabolic activity, or histological scoring (75% vs 83%; p=0.2423). No deaths, adverse events, inflammation, or infection were observed in surviving animals. Limitations include the small animal sample, the difficulty of the murine grafting setting, and the indirect human relevance of the model.

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PMC10407941

In vivo efficacy proof of concept of a large-size bioprinted dermo-epidermal substitute for permanent wound coverage

Frontiers in Bioengineering and Biotechnology

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ABSTRACT

Abstract Introduction: An autologous split-thickness skin graft (STSG) is a standard treatment for coverage of full-thickness skin defects. However, this technique has two major drawbacks: the use of general anesthesia for skin harvesting and scar sequelae on the donor site. In order to reduce morbidity associated with STSG harvesting, researchers have developed autologous dermo-epidermal substitutes (DESs) using cell culture, tissue engineering, and, more recently, bioprinting approaches. This study assessed the manufacturing reliability and in vivo efficacy of a large-size good manufacturing practice (GMP)-compatible bio-printed human DES, named Poieskin ® , for acute wound healing treatment. Methods: Two batches (40 cm 2 each) of Poieskin ® were produced, and their reliability and homogeneity were assessed using histological scoring. Immunosuppressed mice received either samples of Poieskin ® ( n = 8) or human STSG ( n = 8) immediately after longitudinal acute full-thickness excision of size 1 × 1.5 cm, applied on the skeletal muscle plane. The engraftment rate was assessed through standardized photographs on day 16 of the follow-up. Moreover, wound contraction, superficial vascularization, and local inflammation were evaluated via standardized photographs, laser Doppler imaging, and PET imaging, respectively. Histological analysis was finally performed after euthanasia. Results: Histological scoring reached 75% ± 8% and 73% ± 12%, respectively, displaying a robust and homogeneous construct. Engraftment was comparable for both groups: 91.8% (SD = 0.1152) for the Poieskin ® group versus 100% (SD = 0) for the human STSG group. We did not record differences in either graft perfusion, PET imaging, or histological scoring on day 16. Conclusion: Poieskin ® presents consistent bioengineering manufacturing characteristics to treat full-thickness cutaneous defects as an alternative to STSG in clinical applications. Manufacturing of Poieskin ® is reliable and homogeneous, leading to a clinically satisfying rate of graft take compared to the reference human STSG in a mouse model. These results encourage the use of Poieskin ® in phase I clinical trials as its manufacturing procedure is compatible with pharmaceutical guidelines. Keywords: skin substitute, wound healing, multimodal bioprinting, laser-assisted bioprinting, large size, good manufacturing practice compatible

CITATION EXPORT

Maxime Abellan Lopez, Laurence Hutter, Etienne Pagin et al.. In vivo efficacy proof of concept of a large-size bioprinted dermo-epidermal substitute for permanent wound coverage. Frontiers in Bioengineering and Biotechnology. (2023). https://doi.org/10.3389/fbioe.2023.1217655

AUTHORS

22 · 7 CENTRES

Maxime Abellan Lopez, Laurence Hutter, Etienne Pagin, Mélanie Vélier, Julie Véran, Laurent Giraudo, Chloe Dumoulin, Laurent Arnaud, Nicolas Macagno, Romain Appay, Laurent Daniel, Benjamin Guillet, Laure Balasse, Hugo Caso, Dominique Casanova, Baptiste Bertrand, Françoise Dignat, Loïc Hermant, Hélène Riesterer, Fabien Guillemot, Florence Sabatier, Jérémy Magalon

1 Plastic Surgery Department, Hôpital de la Conception, AP-HM, Marseille, France
2 Aix-Marseille Université, INSERM, Institut National de Recherche Pour l'Agriculture, l'Alimentation et l'Environnement, Centre de Recherche en Cardiovasculaire et Nutrition (C2VN), Marseille, France
3 Poietis, Pessac, France
4 Cell Therapy Department, Hôpital de la Conception, AP-HM, INSERM CIC BT 1409, Marseille, France
5 Vascular Biology Department, Hôpital de la Timone, AP-HM, Marseille, France
6 Anatomy and Pathology Department, INSERM U1263, C2VN, Hôpital de la Timone, Marseille, France
7 Centre Européen de Recherche en Imagerie Médicale (CERIMED), Aix-Marseille Université, Centre National de la Recherche Scientifique, Marseille, France