Poietis and Marseille-based hospital partner for bioprinted skin clinical trial
French bioprinting company Poietis has entered into a clinical research collaboration with the Assistance Publique – Hôpitaux de Marseille (AP-HM) to pursue a clinical trial for bioprinted skin tissue. Through the partnership, Poietis and AP-HM aim to carry out a Phase I clinical trial for an Innovative Advanced Therapeutic Medicinal Product (ATMP) for skin healing issues. The timeline for this phase is two years.
Poietis’ overarching goal is to make bioprinting a viable solution for producing human tissues, lessening the demand for organ transplantations. Today, the company has a series of bioprinting products on the market based on its Next Generation Bioprinting platform, including the NGB-R, for in-vitro tissue engineering research, and the NGB-C, for the clinical production of implantable bioprinted tissues.
The Marseille-based AP-HM, for its part, runs a cell therapy unit (headed by Professor Florence Sabatier) that specializes in manufacturing cell therapy preparations (CTP) for routine care, as well as in the delivery of cell therapy medicinal products for clinical trials.
The cell therapy unit, called the Cell Culture and Therapy Laboratory (CCTL), consists of “controlled atmosphere manufacturing areas” which meet the standards set by the Rules of Good Manufacturing Practice for Sterile Medicinal Products for Human Use and ATMP, as well as the Rules of Good Practice for the Preparation, Storage, Transport, Distribution and Disposal of Tissues, Cells and Cell Therapy Preparations.
AP-HM’s CCTL and the hospital’s Department of Plastic and Restorative Surgery and the Interregional Centre for Major Burns will work together to develop innovative skin regeneration technique using Poietis’ bioprinting technology.
“This collaboration is a further step for Poietis and its ambition to place a bio-printer in every hospital to enable the production of personalized tissues and improve the management of patients waiting for transplants,” said Dr. Fabien Guillemot, Founder and President of Poietis. “The successful completion of this project will pave the way for important applications of bioprinting in the medical field.”
Dr. Bertrand, Plastic Surgeon at the AP-HM, added: “Bioprinted skin prepared from a simple sample of the patient’s own cells would greatly simplify the surgical procedure and avoid large skin samples. This therapeutic innovation ‘made in France’ could be a real revolution in the treatment of patients requiring a skin graft, such as severe burns.”
“This collaboration will bring together all the skills required to produce a bioprinted tissue that can be implanted in humans, in accordance with European regulations,” said Dr. Magalon, pharmacist-biologist in the Cellular Therapy Unit. “But this is only one step. Tomorrow, the objective is to bioprint more complex tissues as close as possible to the patient. It is conceivable that all major hospitals will be equipped with bioprinters in the future. This reminds me of the success of surgical robotics: a breakthrough innovation that has become essential in daily practice.”
