"Dipyridamole has proven to be key to the implant's success," says study co-investigator Bruce N. Cronstein, MD, the Dr. Paul R. Esserman Professor of Medicine at NYU School of Medicine, who perfected the drug's use during device testing. Used for more than a half-century to prevent blood clots and treat stroke, dipyridamole has a long-standing safety record, says Cronstein, who also serves as the director of the Clinical and Translational Science Institute, and chief of the Division of Translational Medicine at NYU Langone Health. "And because the implant is gradually resorbed, the drug is released a little at a time and locally into the bone, not into the whole body, thereby minimizing risks of abnormal bone growth, bleeding, or other side effects."

In the latest experiments, researchers used the test scaffolds to repair small holes surgically made in the skulls of mice and missing bone pieces as long as 1.2 centimeters in rabbit limbs and jaws.


The scientists found that on average 77 percent of each scaffold was resorbed by the mammal's body six months after implantation. They also found that new bone grows into the lattice-like structural supports of the scaffold, which then dissolves. Some CT scans of the implant sites showed almost no trace of beta tricalcium phosphate, the 3D-printed material of which the original implants were made.

Subsequent weight-bearing tests showed that the new bone was of equivalent strength as original, undamaged bone.

The investigators say their next studies will test the scaffolds, for which they have a patent pending, in larger animals. They caution that clinical trials are still several years away.

Related efforts in skull reconstruction moving forward will be led by plastic surgeons Eduardo D. Rodriguez, MD, DDS, the Helen L. Kimmel Professor of Reconstructive Plastic Surgery at NYU Langone Health, and chair of its Hansjörg Wyss Department of Plastic Surgery; and Roberto Flores, MD, the Joseph McCarthy Professor of Reconstructive Plastic Surgery, who also directs NYU Langone's cleft lip and palate program.


Funding support for the study was provided by National Institute of Arthritis, Musculoskeletal and Skin Diseases grant R01 AR068593, and U.S. Department of Defense grant W81XWH-16-1-0772.

Besides Coelho and Cronstein, other researchers involved in these experiments--and the principal architects of the computer software and the scaffold's design and construction--are study co-investigators Lukasz Witek, PhD, and Nick Tovar, PhD, both from NYU Dentistry, and James Smay, PhD, at Oklahoma State University.

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