Harnessing the body's innate capacity to heal itself, researchers at the Houston Methodist Center for Musculoskeletal Regeneration are developing dissolvable biomimetic implants that augment recovery from complex bone fractures.

Francesca Taraballi, PhD, the center's director, and her colleagues constructed a collagen-based scaffold device called 3 Zonal Membrane (3ZM), now in cGMP production. The scaffold enhances the structure and composition of growing bones in a way that speeds the repair of complex fractures, which otherwise result in high infection rates, slow or incomplete healing, or even amputation.

Dr. Taraballi has demonstrated that regenerative processes depend upon an intricate dialogue among different types of cells.

"We recognize the human body's incredible capacity to heal and capitalize on it by designing biomimetic implants and materials that boost cell response during healing," Dr. Taraballi says. "With this approach we can rely on the local physiological healing cascade and avoid introducing bioactive stimuli, such as growth factors, which can have undesired side effects."

The Center for Musculoskeletal Regeneration was recently awarded $6 million by the U.S. Department of Defense under the leadership of Dr. Bradley Weiner, a professor of clinical orthopedic surgery, to complete preclinical cGMP assessment of 3ZM technology for a pre-investigational device exemption regulatory consultation with the Food and Drug Administration.

Reinforcing bone from the inside out

In preclinical models, the 3ZM scaffold guided immune cells, stem cells and bone membrane cells to remodel a complex fracture into functional bone. Within six weeks, the bone healed, and the biomimetic implants were absorbed by the body, leaving the bone strong.

During the healing process, 3ZM is cut and shaped to fit a defect site and then sutured to the surrounding periosteum. The process requires only one operation.

After four to six weeks, the bone is fully healed, and the 3ZM is absorbed.

Center leaders have worked with industry partners, regulatory experts and policymakers to accelerate the biomimetic implants' path to clinical application.

Innovative materials take center stage

The mission of the Center for Musculoskeletal Regeneration is to restore the structure and function of the musculoskeletal system to alleviate disease and chronic pain.

The center is a multidisciplinary, translational research laboratory with scientists who harness the body's natural healing capabilities and use them to their fullest potential for drug delivery and tissue engineering applications. Scientists within the multidisciplinary translational research laboratory leverage their expertise in nanomedicine, engineering, chemistry, biology and materials science to perform cutting-edge research designed to facilitate technology translation to the clinic.

"We aim to accelerate the rate at which nanotechnology and tissue engineering move from bench to bedside," Dr. Taraballi said. "Our efforts are directed towards the treatment of currently unmet traumatic and pathological musculoskeletal needs using innovative medical technologies that work within, not around, the laws of nature."