Bone fractures are incredibly common, with nearly 8 million each year in the United States alone. The time it takes to heal varies depending on the bone, individual, and extent of injury, but some can take months on end and require bone grafts. A new product seeks to reduce healing time by giving the bone a protected, enclosed space in which to regrow bone tissue.
Israel-based Regenecure has developed a thin, flexible membrane that is affixed to a broken bone like wrapping paper. It is easily trimmed to fit any size injury, which makes mass production a bit easier, and physicians can create a custom fit for each patient. Like all other membranes, this material selects what can and cannot come through. In this case, fluid is allowed in, but soft tissue which can impede the healing process is blocked out. While this application is new, the material is not. It is a thin, Saran Wrap-like material which was invented in Germany, where it was used to cover tablets to control the release of oral medications in the stomach.
Application requires only one surgical procedure. Once it is implanted, the membrane serves a scaffold where stem cells are able to come into the injury site and begin to proliferate and differentiate.
The team conducted trials on sheep bones, which are fairly similar to human bones in terms of density and regenerative properties. It is commonly used as an animal model when exploring new bone implant materials. Sheep that experienced considerable bone loss were treated in one of four ways: splint only, splint with bone graft substitute, splint with membrane, and splint with membrane and bone graft substitute.
The bones that only received a splint did not heal, as the bone loss was too severe and the body was not able to bridge those large gaps on its own. Those that received a bone graft substitute took 28 weeks to heal. The treatment with the membrane also took 28 weeks, though the researchers noted that the bone healed more completely. The combination of membrane and bone graft substitute was able to cut the healing time in half at 14 weeks, with some individuals healing in only 8 weeks.
Regenecure’s membrane has been approved for veterinary use and 200 animals have already received the treatment with no side effects or complications recorded. The company is currently performing randomized human trials this year in dental implants. Half of the participants received a traditional collagen membrane while the other half use the Regenecure membrane. The trial participants will be monitored up to six months after the implant to investigate any side effects as well as investigating the completeness of the healing.
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