News Releases & Research Results Development of an artificial protein to cure intractable wounds - Implementation of a company-initiated clinical trial after an investigator-initiated clinical trial through industry-government-academia collaboration -

The results of collaborative R&D conducted by Assistant Professor Kazuo Noda of the Department of Plastic and Reconstructive Surgery, Graduate School of Medicine Kyoto University and Sanyo Chemical Industries, Ltd.

• A novel therapeutic material, silk elastin sponge*, was developed to treat intractable wounds (chronic wounds), such as diabetic skin ulcers.
  * An artificial protein produced by combining the partial sequences of silk fibroin (a fibrous protein produced by silkworms and the raw material of silk) and elastin (the main protein of elastic fibers) by genetic recombination technology.
• As demonstrated in animal experiments, the novel therapeutic material was also effective for chronic wounds susceptible to infection. Subsequently, an investigator-initiated clinical trial was conducted in patients with intractable leg ulcers at Kyoto University Hospital, demonstrating the safety of the material.
• In the future, the investigator-initiated clinical trial at Kyoto University will be advanced to conduct a company-initiated clinical trial to examine the efficacy of the novel therapeutic material, and research and development will be carried out to obtain approval for a new medical device within four years.

This R&D project was conducted with the support of Development of Medical Devices through Collaboration between Medicine and Industry by AMED.