A new product, developed out of research at Carnegie Mellon University and Allegheny General Hospital, could change the face of bone fracture treatment. REPAIR Bone Putty is a biologically active material that can be applied directly to a wound to enhance the healing process.
The malleable substance, made from platelet-rich plasma, or PRP, may also be used during orthopedic, plastic, neurological, spinal and even dental and facial surgeries, explains James Burgess, a neurosurgeon at Allegheny General Hospital and one of the inventors of REPAIR Bone Putty.
Two other researchers from Carnegie Mellon University, Lee Weiss, research professor in the Robotics Institute and the Department of Biomedical Engineering, and Phil Campbell, research professor in the Institute for Complex Engineered Systems and the departments of Biology and Biomedical Engineering, also developed the product.
The three are currently in the process of obtaining additional funding necessary to bring the product to market, hopefully by early 2016 in Europe, says Weiss.
They recently completed their first clinical study to demonstrate the product’s safety.
During that trial – a year-long, 30-patient study that took place in South Africa – patients with trauma-induced tibia fractures were placed in either a control group or a treatment group. The treatment group received REPAIR Bone Putty placed in the substance of the fracture during their surgeries, explains Weiss.
They discovered the putty had much more impact than anticipated.
“We did show efficacy in wound healing. The surprising benefit is we had lowered the infection rate,” says Weiss.
Infections developed in 80 percent of the control group as compared to only 16.7 percent in the treatment group, he says.
Burgess says that the material is based on tissue engineering platform technology and will have many uses.
“We see this as an accelerator toward bone healing … (as in) complex fractures, like a bone reconstruction of the face or jaw or the spine when trying to have large pieces of bone knit together,” he says.
Applied to frequently changed bandages, it could also be used on “dirty” burns to prevent infections, he adds.
REPAIR Bone Putty is manufactured by Carmell Therapeutics, the company Weiss, Campbell and Burgess co-founded to commercialize the putty, located in the Institute for Transfusion Medicine at the Central Blood Bank on the Boulevard of the Allies. It is made from PRP from a healthy population of donors. After a proprietary process to inactivate any unknown pathogens, the PRP is clotted, dried and ground into a powder. Next it is mixed with a biocompatible plasticizer to form a dough and a solid bio-plastic material.
“It is intended to dissolve into the tissue,” says Dr. Burgess, noting they can fine-tune the time frame of how long it takes to dissolve.
Also encouraging, the material is inexpensive and will be sold “off-the-shelf” in putty, sheets and an extrudable material for $200 or less if necessary, says Weiss. It will be affordable in South Africa, where it was tested, and even third world countries.