A French hospital installed a bioprinter to manufacture biological tissues for transplantation in humans. This quantum leap in bioprinting is possible thanks to Poietis, a local biotech company specializing in the design of regenerative medicine therapies and proprietary 4D laser bioprinting technology. As the recipient of Poietis’ Next-Generation Bioprinting (NGB) robotic system, the Hôpital de la Conception, which is part of the Marseille Public University Hospital System (AP-HM), will start using the device as part of a clinical trial for grafting bioprinted skin tissue using patients’ own cells.
Installed at the Hôpital de la Conception’s Advanced Therapy Medicinal Product (ATMP) manufacturing area, the device represents a real technological revolution for the healthcare sector. In fact, it is the result of a collaboration between Poietis and the AP-HM’s Cell Culture and Therapy Laboratory (LCTC) that began in early 2020 to overcome the challenges of currently available bioprinting processes.
According to Poietis, the current manufacturing methods of biological tissues are not good enough to be adopted by the medical community, even though several extremely promising advances paved the way for new therapeutic strategies in tissue repair and substitution. Experts at AP-HM and Poietis consider that the “manufacturing processes need to be standardized,” and treatments should be more affordable.
Up until now, various bioprinting technology platforms have been developed to meet these challenges. Still, none of them has proved compatible with the Good Manufacturing Practices regulations associated with manufacturing advanced therapy medicinal products (ATMPs). So, no bioprinted biological tissue has yet been implanted in a patient.
Commenting on the new on-site bioprinting technology, Poietis founder and president Fabien Guillemot said, “bioprinting is entering a new era. The development of the first bioprinting platform that complies with the Good Manufacturing Practices (GMP) of ATMPS is a breakthrough innovation in the field of regenerative medicine as it removes one of the last barriers before grafting bioprinted tissues into patients.”
The NGB bioprinting platform, developed by Poietis and recently installed in the AP-HM hospital, meets these challenges thanks to numerous technological advances, including the integration of laser-assisted bioprinting and 3D extrusion biomaterial printing technologies in a completely aseptic environment. Moreover, the robotization of the platform and the automation of the processes allow the production of functional tissues with a high level of reproducibility and flexibility.
As if that weren’t enough, the collaboration between Poietis and the French hospital resulted in a thousandfold increased printing speed, which lets users make 40 square centimeters (6.2 square inches) of skin substitutes in a few hours. As a reference, British experts have estimated the average surface area of the skin in adult women to be roughly 16,000 square centimeters (2,480 square inches) and 18,000 square centimeters (2,790 square inches) in adult men.
Doctors will be able to bioprint a large quantity of skin at the hospital thanks to a simple sample taken very easily from the patient. This is a therapeutic innovation that AP-HM plastic surgeon, Maxime Abellan-Lopez, says he has been waiting for. It “offers us the capacity to reconstruct the skin of patients requiring a graft, such as after a burn or serious trauma, with minimal adverse effects.”
The team at the hospital will bioprint a proprietary tissue model engineered by Poietis known as Poieskin. Described as a “human full-thickness skin model,” Poieskin consists of a dermal compartment composed of primary human fibroblasts embedded in a collagen I matrix overlaid by a stratified epidermis (the outermost layer of the skin) and derived from primary human keratinocytes–the primary type of cell found in the epidermis. As for the biofabrication process, it begins with dermis bioprinting and dermis maturation, followed by keratinocytes bioprinting, epidermal proliferation, and stratification at the air-liquid interface.
A mature epidermis functions as a barrier that protects the body from dehydration or trauma. Recreating it using a bioprinting capability like Poietis could improve the repair of burn injuries. Typically, burn treatment, especially in the case of third- and fourth-degree burns, require specialized medical care involving the surgical removal of the injured skin and reconstruction of the burn injury using skin substitutes, like grafts. Ever since bioprinting has been suggested for treating burn wounds, the potential applications for the technology have been very promising. Admittedly, the clinical trial translation must meet the necessary technological and regulatory challenges before it becomes available to patients.
However, Poietis and the AP-HM are moving fast. Thanks to the latest recommendations from the French Agency for the Safety of Health Products, the LCTC will finalize the validation of the Poieskin skin substitute manufacturing process before starting a clinical trial next year, which will be carried out with the support of the AP-HM’s Plastic and Reconstructive Surgery Department and the Interregional Center for severe burns.
Although the medical center is focused on grafting human tissue using a bioprinter, the ultimate goal is to bioprint more complex tissues at the point of care, as close to the patient as possible. Like many medical doctors, the team at AP-HM dreams about equipping hospitals with bioprinters, where at-risk patients can have access to the artificial creation of human skin, tissue, and even someday, internal organs. Although this seems far away into the future, Poietis is readying the basis for what is to come.
“In the future, we can envision all major hospitals being equipped with bioprinters. This reminds me of the success of surgical robotics: a disruptive innovation that has become essential in daily practice,” described LCTC pharmacist-biologist Jérémy Magalon.
For now, this installation is a significant milestone that will set off the commercialization of NGB-C bioprinters to cell therapy and translational research centers in France and eventually Europe and the US. It will also help Poietis accelerate the development of its portfolio of implantable bioprinted tissues for wound healing in the osteoarticular field and for treating neurodegenerative diseases.
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