Poietis signs a clinical research collaboration contract with the Assistance Publique – Hôpitaux de Marseille (AP-HM) to prepare the first clinical trial of a bioprinted skin

Poietis, leading bioprinting company, and the « Assistance Publique – Hôpitaux de Marseille » (AP-HM) announced today that they have entered into a partnership through the signature the 20th of January of a clinical research collaboration contract on a bioprinted tissue engineering product. The objective of this agreement is to carry out within two years a Phase I clinical trial of an Innovative Advanced Therapeutic Medicinal Product (ATMP) responding to would skin healing issues.

The development of tissue engineering and the manufacture of implantable biological tissues represent major socio-economic challenges. The global market for tissue engineering and regeneration is expected to grow from $24.7 billion in 2018 to $109.9 billion by 2023 (source: BCC Research). As a result of longer life expectancy and the incidence of major pathologies such as cancer and diabetes, the number of people waiting for an organ transplant is constantly increasing: at the end of 2016 in the EU member countries more than 142,000 patients were waiting for a kidney, liver, heart, lung, pancreatic or intestinal transplant (source: EDQM Council of Europe).

Poietis is a biotechnology company specialized in the development and manufacturing of human tissues by bioprinting. Its main mission is to develop new therapeutic solutions based on its expertise in bioprinting technologies and in particular high-resolution laser assisted bioprinting. Poietis has developed the multimodal NGB (« Next Generation Bioprinting ») bioprinting platform declined in two versions: one for in vitro tissue engineering research (NGB-R) and a clinical version (NGB-C) for the production of implantable bioprinted tissues. This multimodal, automated biomanufacturing platform enables tissue engineering researchers to achieve superior tissue engineering results through high resolution, and enables the fabrication of complex tissues with repeatability and reproducibility.
The AP-HM, and more particularly its « cell therapy unit » headed by Professor Florence Sabatier, has the manufacturing authorisation and expertise to manufacture, control and deliver cell therapy preparations (CTP) in the context of routine care, as well as expertise to manufacture, control and deliver innovative cell therapy medicinal products in the context of clinical trials conducted by the AP-HM (exploratory ATMPs and ATMPS ponctually prepared).

AP-HM’s Cell Culture and Therapy Laboratory (CCTL) is a platform, consisting of « controlled atmosphere manufacturing areas » in accordance with the requirements of the regulations dictated by the « Rules of Good Manufacturing Practice for Sterile Medicinal Products for Human Use (GMP 2019) and ATMP » and by the « Rules of Good Practice for the Preparation, Storage, Transport, Distribution and Disposal of Tissues, Cells and Cell Therapy Preparations ».

The Department of Plastic and Restorative Surgery and the Interregional Centre for Major Burns of the AP-HM, directed by Pr Dominique Casanova, work in close collaboration with the Culture and Cellular Therapy Laboratory to develop innovative skin regeneration techniques. However, there is no technique available in daily practice that can effectively replace the skin graft taken from the patient himself.