A Phase I/II Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures
Restrictive Scar Contracture Injuries in Military Members and Civilians
Restrictive scar contracture (a condition where tissue thickens and tightens, pulling the surrounding healthy skin toward the damaged area) due to a serious burn injury can result in long term aesthetic and physical consequences.
Skin contractures adjacent to a joint lead to joint deformities that severely restrict range of motion (ROM) of the affected joint. Skin contractures are also often accompanied by crippling levels of chronic pain resulting in a high level of dependency on pain medications. These isolated or combined factors can lead to a significant disruption in both social and professional life, leading to a marked impact on an individual’s quality of life.
The current standard of care for restrictive scar contracture involves the surgical excision of the contracture itself and/ or skin grafting. These standard therapies require extensive and often repeated surgeries. Physicians are continually seeking less invasive therapies to treat patients with burn contractures.
What is a ICX-RHY-013 Investigational Drug?
ICX-RHY-013 (Allogeneic human dermal fibroblasts), is investigational and not yet approved by the U.S. Food and Drug Administration (FDA).
Procedure Provided as Part of a Research Study
In this clinical trial funded by the Department of Defense, all procedures for this research study will be performed at UPMC facilities.
Eligibility Criteria
Men and women, military or civilian, age 18 to 65 years of age may be eligible. Research candidates who have suffered an injury (excluding facial injuries) that has resulted in a stable restrictive scar contracture. The injury must be at least 6 weeks out from the initial injury in order to be evaluated.