After years of investigating ways to manage treatment for diabetic foot ulcers (DFU), Korean 3D bioprinter manufacturer, Rokit Healthcare finally announced the success of a new DFU regeneration platform based on its 4D bioprinting technology for customized tissue regeneration. This new and alternative method for chronic wound healing promotes a mechanism of skin reconstruction for DFU treatment that was successfully tested on patients and will be globally commercialized this year.
To find an advanced treatment method, particularly for wound healing, Rokit tested the DFU therapy with its own 4D bioprinting system, using a personalized bioink developed with the patient’s own adipose tissue that had no immune rejection.
With diabetes on the rise in most countries, patients require targeted therapies and effective solutions for pain management. Today, over 460 million adults have diabetes, that’s roughly 6% of the global population, and it is expected to reach 700 million patients by 2045. Furthermore, diabetes can damage eyes, kidneys, and nerves, cause heart disease, stroke, and even the need to remove a limb. In fact, diabetic foot ulcerations are one of the most common complications associated with diabetes, as an estimated 50% of diabetic ulcers become infected and could result in amputation.
Rokit’s mission is to decrease the rate of amputation for patients with DFU, by offering safe and effective regenerative therapy based on 4D bioprinting technology. As part of one of their continuing studies, a global Rokit team successfully tested its DFU regeneration platform on patients in India and will continue clinical trials in South Korea, Europe, North America, and East Asia.
The process begins with fat tissue taken from a patient (for example through liposuction), which is then used to prepare an autologous extracellular matrix (ECM) mixture to form a bioink that is loaded into Rokit’s INVIVO 4D bioprinter to produce a dermal patch. The autologous patch is finally implanted at the wound site after the damaged tissue has been removed.
The results of the study, published in the American Diabetes Association‘s journal Diabetes, describe how the autologous ECM patch, applied onto the chronic wound site of DFU patients, resulted in a significant wound size reduction after only a one-time treatment.
During the tests, most of the patients showed complete closure of the wound in only two to five weeks. In fact, after a 14-day skin wound healing process, the treated wound area had more effectively reconstructed epidermal and dermal structures when compared to the non-treated wound areas.