Though there are many medical devices that can be used in the care of advanced wounds, there is significant clinical research to support that biological therapies provide superior healing ability. IDTechEx has previously reported on how connected sensors, imaging technologies and diagnostics testing can be used in the care of advanced wounds, but a significant portion of our company's research focuses on the use of living therapies, such as those manufactured using tissue engineering and 3D bioprinting technologies.
Biological therapies can provide essential building blocks such as growth factors, living cells and extracellular matrix material to heal stalled wounds. While patients can receive skin grafts from other areas of their own body, this may not be suitable for all. For example, a patient suffering from extensive burns would not have enough healthy skin to use. In such a situation, physicians may turn to one of several cell- and tissue-based products available for the treatment of advanced wounds. These products include bioengineered living cell therapies, extracellular matrices, and amniotic therapies.
Bioengineered tissue therapies are one of the more advanced technologies used in wound care, and even they have been on the market for 20 years. The benefit of using living cells is that after release of growth factors, the cells will continue to secrete collagen, growth factors, and other mediators which help the healing process. Developed by Organogenesis, Apligraf is the only bioengineered living skin substitute approved by the FDA for the treatment of venous leg ulcers and diabetic foot ulcers. Apligraf is an off-the-shelf product manufactured using an established tissue engineering process and consists of a layer of keratinocytes and a layer of fibroblasts grown in bovine collagen.
Though off-the-shelf therapies such as Apligraf are convenient for both doctors and patients alike, bioengineered tissues are moving towards personalized therapies that are grown from the patient's own cells. Epicel, a cultured epidermal autograft commercialized by Vericel, was approved by the FDA in 2007 for the treatment of extensive burns over 30% of the patient's total body surface area. To create the therapy, keratinocytes are collected from the patient, and sent to the company where it is expanded in the lab to form skin. It is then shipped back to the doctor for application to the patient. The whole process can take up to 21 days.
There are several companies following in Vericel's footsteps in the creation of personalized bioengineered skin therapies for the treatment of burns. Companies such as Amarantus Bioscience, Cutiss, and Upside Biotechnologies have moved in to the field. Cutiss' denovoSkin is currently in Phase II clinical trials, and Upside Biotechnologies is aiming to enter clinical trials in 2020 with their PelliCel product. The initial focus for both products is the treatment of severe burns.
There are several other biological therapies on the market today and many more currently in development. As regulators focus now on advancing regenerative medicine, we will see increasing commercial activity, and thus many more advanced therapies being brought to market. In the future, bioengineered tissues may be manufactured at greater scales using technologies such as 3D bioprinting, or patients may even have their therapy directly 3D bioprinted into their wound.
Learn more at the next leading event on the topic: Business and Technology Insight Forum. Boston, June 2019 on 4 - 6 Jun 2019 at Hilton Boston/Dedham, USA hosted by IDTechEx.