Principal Investigator: Geoffrey Gurtner, MD
Performing Organization: University of Arizona
Burn injuries are among the most devastating of all injuries and a major global public health burden. Severe (full- and deep partial-thickness) burns are a significant challenge among military service members, often leading to debilitating hypertrophic scar (HTS) formation and scar contractures that severely compromise normal function. The current standard-of-care for severe burn wounds is the spit thickness skin grafts (STSG), which provides wound coverage. However, skin grafts often still result in scar contractures and other disadvantages including fragility, abnormal pigmentation, rough texture. Additionally, skin grafts do not allow for healing of natural skin appendages (structures in the skin controlling sensation, contractility, lubrication, and heat loss), such as hair. Currently, there are no standardized pharmacological options for patients with deep burn injuries to prevent scarring and contracture, and there remains an urgent need to develop effective therapies to alleviate post-burn scar formation and improve outcomes of this devastating medical condition.
For the military, an ideal therapy for acute burn wounds would be not only effective, but also easy-to-use in various settings by military paramedics even under minimal infrastructural support. For the past 15 years, the research laboratory of Dr. Geoffrey C. Gurtner, MD, has comprehensively investigated the role of mechanical forces during human disease1-3. While we have successfully developed a commercially available medical device to physically unload the skin (Embrace Scar Therapy at Neodyne Biosciences, Inc.) to reduce scarring following surgical incisions2, we cannot use those devices on large or irregularly contoured body areas. To address this, we have developed a drug hydrogel to target the same molecular pathways in cells to mitigate scar formation and promote skin regeneration. Specifically, we have demonstrated in several preclinical animal studies that a focal adhesion kinase inhibitor (FAKI) can be applied to extensive second- and/or third-degree burn wounds and/or STSG immediately after injury to reduce fibrosis and enable scarless regeneration1,3.
Our research builds upon several years of work developing and investigating a biocompatible, controlled drug delivery system for a small molecule FAKI in several clinically relevant animal models. We are performing final FDA enabling studies to mass produce the drug and hydrogel for clinical trial use. The primary objective of our proposed first-in-human clinical trial is to determine whether FAKI therapy is safe in burn injury subjects who require STSG. Our primary target population will be patients with deep partial- or full-thickness burns who are undergoing skin grafting. Burn patients will be recruited from the University of Arizona/Banner University Medical Center (UA/BUMC) (PD/PI: Dr. Geoffrey Gurtner). This investigator-initiated Phase I/IIa trial is anticipated to confirm the human safety of locally delivered FAKI therapy and also provide an early indication of efficacy. Successful completion of this proof-of-concept human study will provide a new therapeutic approach widely applicable for scar management in all burn wounds and, in the future, other traumatic injuries.
Our therapeutic can be applied to severe burn wounds with or without standard of care split thickness skin grafts (STSG) immediately after the injury to reduce scar contracture and promote skin regeneration and rapid healing. This therapy can be simply unpackaged, soaked in saline, and used identically to standard of care hydrogels/wound dressings. Application of this therapy requires minimal infrastructural and technical support, making it easily used by all military members in any setting.
1Chen et al., 2022, Sci Transl Med. 2Gurtner et al., 2011, Ann Surg. 3Chen et al., 2021, Nat Comm.