Gemstone Biotherapeutics LLC (Gemstone Bio), a Baltimore-based biotechnology company and pioneer in the field of regenerative medicine, has announced the publication of a peer-reviewed scientific study "Acellular Hydrogels for Regenerative Burn Model Healing: Translation from a Porcine Model" in the Journal of Investigative Dermatology. The advance online publication is now available at Nature.com. The paper was authored by Yu-I Shen, Hyun-Ho G. Song, Arianne E. Papa, Jacqueline A. Burke, Susan W. Volk and Sharon Gerecht.
The study measured the efficacy and wound healing properties of Gemstone Bio's patented hydrogel solution. This technology was evaluated in pigs, which have anatomically and physiologically similar skin to humans.
Results of the study demonstrated the technology's significant wound healing performance. All third-degree burns treated with Gemstone Bio's advanced hydrogel technology achieved complete wound closure after two weeks, compared to only 14 percent of the control-treated wounds.
The technology works by eliciting an earlier and more controlled inflammatory response, which stimulates rapid neovascularization, i.e. blood vessel formation, and supports efficient dermal reconstruction to close the wounds with minimal scarring. The regenerated skin demonstrated characteristics of uninjured skin. Wounds treated with the technology produced increased amounts of the dermal proteins collagen and elastin, which help to minimize scarring and strengthen the repaired tissue. These wounds were reinnervated throughout, with nerve fibers extending through the center of the reconstructed skin.
"Our core hydrogel technology, the foundation for our biosynthetic scaffold product, facilitated a superior wound healing response by accelerating skin regeneration," said Dr. Laura Dickinson, Gemstone Bio's director of research and development. "Third-degree burns, which normally heal with thick distorted scars with permanent sensory loss, were healed with complete re-epithelialization (wound closure) and nerve ingrowth."
This technology is being further developed and commercialized for expected therapeutic use in a variety of acute and chronic wounds.
In the United States, chronic wounds, including diabetic foot ulcers, venous leg ulcers and pressure ulcers, affect upwards of 6.5 million patients. The global wound care market is expected to reach $18.3 billion by 2019. This burden is growing rapidly due to increasing health care costs, an aging population and a sharp rise in the incidence of diabetes and obesity. Effective treatment of these wounds, from both clinical and cost perspectives, remains an unmet challenge.
"Gemstone Bio's hydrogel solution represents an ideal, low-cost, off-the-shelf biosynthetic treatment for a range of dermal injuries," said George Davis, CEO of Gemstone Bio. "We are encouraged by the continuing verification of the technology through ongoing rigorous testing and studies. These results are paving the way forward towards a commercially available therapeutic solution."
The technology previously demonstrated similar positive results when evaluated in mice, including the regeneration of complex dermal features such as hair follicles and sebaceous glands. The results of the study conducted on mice paved the way for the recent pig study, which has greater concordance with human trials and is therefore significantly more translationally relevant. Although not yet tested in humans, the current study affirms the superior wound healing performance of Gemstone Bio's biosynthetic scaffold technology.