Natural Infection Reduction: First Reported Use of a Novel Blood Plasma-based Product for Treating Open Tibia Fractures

August 21, 2014

Military Health System Research Symposium (MHSRS), Fort Lauderdale, FL – Dr. Jason Smith, Director of Research and Development at Carmell Therapeutics, today presented data from a recently completed clinical study in South Africa on the use of Carmell’s REPAIR™ Bone Putty to augment the healing of open tibia fractures. Open fractures are problematic to treat as infections, bone healing and wound closure/sepsis are significant problems. In this study involving 30 patients, 70% had more severe type IIIA & IIIB injuries involving comminuted (crushed) bone, high levels of contamination and severe soft tissue injury. Additionally, 67% of subjects were smokers, a factor known to retard healing, and 70% received external fixation with an associated high rate of pin-tract infections.

The REPAIR Putty incorporates a bio-active material manufactured from blood plasma containing a concentration of natural plasma and platelet-derived healing factors which bathe the injured tissue as the material degrades over several weeks. While it was anticipated that the putty would accelerate bone healing and wound closure, a surprising result from the study was a significant reduction in infections. Eighty percent of control patients had at least one infection through the one-year study, compared to only 22% of the putty treated injuries. When examining the more severe type IIIA & IIIB injuries, the difference was even more dramatic with 100% of controls vs. 25% of treatment patients experiencing at least one infection. In both cases the differences were statistically significant. The infection rates of 80% and 100% for the controls are quite high and are largely due to the use of external fixation. When pin tract related infections were removed from the database, the control group had a 43% infection rate for the more severe IIIA and IIIB injuries, which compares well with the reported literature; by contrast, the putty group in this subset had only a 17% infection rate. The Company believes that the infection reduction is largely due to the blood plasma component of the putty not only eluting natural regenerative factors but also recruiting the body’s immune system to the area of the injury over several weeks – thereby inciting the body’s own ability to fight off infections. This result is very significant for trauma patients, especially in the military where such injuries are highly contaminated. The use of high levels of antibiotics is frequently used prophylactically to prevent infection, but the rise of antibiotic-resistant infections is raising new concerns.

“We are very excited about the outcomes of this first clinical trial” stated Alan West, Carmell’s president and chief executive officer. “We hoped to see accelerated bone healing with faster wound closure, but the real surprise and perhaps the most important outcome of the study was the infection reduction observed. Our plasma-based products can be viewed simply as highly concentrated blood clots that slowly degrade at a rate we can control. By recruiting the body’s own immune system to the site of the injury over several weeks, the REPAIR Bone Putty safely and naturally reduces or eliminates infections. It is a very powerful but elegantly simple outcome.” The Company plans to release the full findings of the study following presentation at the Congress of the South African Orthopaedic Association on September 1st.

About MHSRS: The Military Health System Research Symposium (MHSRS) is the largest gathering of researchers is the Department of Defense’s (DoD) premier scientific meeting. This Joint symposium provides a collaborative environment for military medical care providers with deployment experience, DoD scientists, academia, and industry to exchange information on research and health care advancements within the areas of Combat Casualty Care, Military Operational Medicine, Clinical and Rehabilitative Medicine, and Military Infectious Disease Research Programs. It emphasizes common areas of knowledge in order to maximize synergy among all branches of the military service, while acknowledging service-specific capabilities. MHSRS is the only scientific meeting that addresses the unique medical needs of the Warfighter.