Scientists from EpiBone, a Brooklyn-based biotech company, are now testing growing bones from stem cells. The process involves taking a fat tissue sample from which to extract the stem cells, and a CT scan of the bone they want to engineer. These will be used to create the shape of the bone, or what Nina Tandon, CEO and co-founder, call a “scaffold.” Cells are then infused into the scaffold, and over about three weeks the cells mature into a piece of bone that’s ready for implantation.
The company claims that this process is better than conventional reconstructive procedures since making new bones is more sustainable that cutting a piece of bone out of one part of the body and transplanting it on another. Tandon hopes patients would no longer need immunosuppressant drugs. She tells Scientific American “…there would be a recognition that it’s the body’s own, since it’s your own DNA.”
Biomedical engineer Warren Grayson of Johns Hopkins University is a shareholder in EpiBone. Even with his obvious interest in the company’s success he tells Business Insider that EpiBone is having “some challenges making it work in patients.” The company’s first hurdle is getting federal approval, which may prove difficult.
Typically, the Food and Drug Administration requires years of heavy study and testing. Even more, since the process uses living tissue, the bar for federal approval may be set even higher, according to professor of biomedical engineering at Case Western Reserve University, Steven Eppell.
Tandon says they are currently doing animal experiments, and are about 18 months away from human trials. The goal is to have the bone in the market by 2023. If the research is successful, the application will be a great leap forward in medical technology. After blood, bone is the most transplanted material in the U.S. alone.