September 3, 2014
South African Orthopaedic Association Congress, Cape Town – Data presented this week from a recently completed clinical trial with the REPAIR™ Bone Putty show the blood plasma-based Putty reduced infections, sped bone healing, and promoted more rapid wound closure of open tibia fractures. Dr. David North, an orthopaedic surgeon associated with the University of Cape Town, presented the findings.
The REPAIR Putty incorporates a novel material made from blood plasma containing a concentration of natural healing factors that bathe the injured tissue as the material degrades. This first study was designed to assess the safety and performance of the Putty in augmenting the healing of fractures.
“We were very pleased and a bit surprised by the results”, said Dr. Brian Bernstein, Principal Investigator for the study, Director of the Orthopaedic Trauma Group in Cape Town and Chairman of the South African Orthopaedic Trauma Society. “We are always concerned about infections with open bone fractures, and the idea of using a concentration of natural growth factors to augment healing and reduce infections is especially attractive, particularly if such a product can be offered at a reasonable cost.”
Open fractures are problematic to treat as infections, delayed bone healing, and wound closure/sepsis are significant challenges. In this 30 patient trial, 70% of the patients enrolled had more severe type IIIA & IIIB injuries involving comminuted bone, high levels of contamination and severe soft tissue injuries. Additionally, 67% were smokers, a factor known to retard healing, and 70% received external fixation that uses pins to penetrate the skin and stabilize the fracture, with an associated high rate of pin-tract infections.
Patients agreeing to participate in the study were randomly placed into either a control or treatment group. The REPAIR Putty was placed into the fracture site during fracture reduction of the treatment patients, and both groups were followed for one year. No adverse events associated with the use of the Putty were observed for the 20 treatment patients. A statistically significant acceleration of bone healing occurred at 180 days with more rapid wound closure at 30 days approaching significance for the treatment patients compared to the controls.
While the Company anticipated that the Putty would accelerate bone healing and wound closure, a big surprise was the reduction in infections. Eighty percent of control patients experienced at least 1 infection during the study compared to only 22% of the Putty treated injuries, a statistically significant difference.
“We are very excited about the outcomes of this first clinical trial” said Alan West, Carmell’s CEO. “We had hoped to see accelerated bone healing with faster wound closure, but perhaps the most important outcome of the study was the infection reduction observed. The REPAIR Bone Putty safely and naturally reduced infections and accelerated both bone healing and wound closure. No competitive product can accomplish all three endpoints.”
With the most severe type III injuries, the infection reduction was even more significantly reduced with 100% of controls vs. 25% of treatment patients experiencing at least 1 infection. The relatively high rates of infection for the controls (80% &100%) were due to the use of external fixation. When pin related infections were removed from the data, the control group had a 43% infection rate for the more severe 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 as it degrades, thereby leveraging the body’s own ability to fight off infections. This result is most significant for trauma patients - high doses of antibiotics are typically given prophylactically to prevent infection, but the rise of antibiotic-resistant bacteria is raising new concerns about antibiotic overuse. The REPAIR Bone Putty may become a game changer in the way these fractures are treated.