Updated, 9/3, 9:42 a.m.
Human bone isn't what comes to mind when most people think of a commercial product, but a group of Columbia researchers hopes to change that.
EpiBone, which just secured lab space in Harlem BioSpace, is researching how to grow human bones using patients' adult stem cells, which, if successful, could vastly improve bone replacement surgeries.
EpiBone is a new company, but members of the founding team have been conducting the base research for years, the longest-standing component of which is 15 years of bone-tissue engineering research done by Gordana Vunjak-Novakovic and funded by the National Institutes of Health. Research has been ongoing both in the Lab for Stem Cells and Tissue Engineering and at the Louisiana State University School of Veterinary Medicine, where EpiBone has successfully grown bone implants for pigs.
EpiBone will continue preclinical work on pigs for approximately the next three years. The researchers will likely enter the trial phase of this work next month.
“In the meantime we've been talking to the FDA about what they want to see. Once we start, we're going to be conducting preclinical trials,” said EpiBone Chief Scientific Officer Sarindr Bhumiratana, who received his doctorate from SEAS and is currently a postdoctoral researcher.
After the preclinical trial phase, the lab will start three phases of clinical trials with humans, which they hope will culminate in a marketable product—human bone implants.
EpiBone CEO Nina Tandon, Business '12, said that the process will take EpiBone about eight years.
“There's some studies that we have to do in order to show longer-term data in pigs, and some tracking of the cells and scaffolding. And that's what the three-year plan is right now,” said Tandon, who began her bone research as a Ph.D. and then as postdoctoral researcher at Columbia's Laboratory for Stem Cells and Tissue Engineering.
Researchers at the start-up used fat-derived adult stem cells, which is attached to the bone scaffolding and grown into a replacement bone inside a bioreactor that pumps in the necessary materials and removes waste. The result is a live bone that cannot be rejected by the body because it was grown from the pig's own cells.
Researchers hope to duplicate this process with humans.
“It's the right shape, it's matched to the patient, it has a better fit in terms of size. Secondly, it's made from the patient's own cells,” Tandon said. “Because it's alive, it also doesn't need any more revision surgery because it grows with the patient. And you can grow it to the size it needs to be clinically.”
If EpiBone is successful in creating a marketable bone implant, it could replace autografts as the leading type of implant in bone-related surgeries. An autograft is a bone implant that is removed from another part of the body and whittled into the approximation of the bone to be replaced before being surgically implanted.
“The reconstruction is never precise,” EpiBone Chief Clinical Advisor Sidney Eisig, the chair of hospital dentistry at the College of Dental Medicine and the director of oral and maxillofacial surgery, said about autografts. “It's usually good enough, but good enough doesn't mean it's precise. And precise would be better I think this [EpiBone] is going to have a real application.”
Eisig said that researchers have yet to determine a price for the product, but that it would be either the same price or cheaper than an autograft because the EpiBone procedure would only require one surgeon and cut back on time in the intensive care unit.
EpiBone made up one of 13 teams selected for the first year of the Innovation and Entrepreneurship at Columbia program at the Business School in 2012.
“We are all engineers, we're scientists—business planning is not our thing,” Bhumiratana said. “And we've gone around pitching and we found a company at the end of the program last summer, and then that's how it all started.”
EpiBone's research has received $600,000 so far, including a $350,000 grant from Breakout Labs last June. Epibone hopes to receive the $3.5 million needed to complete preclinical trials from a combination of grants and private investors.
Because of EpiBone's close ties to Columbia, Tandon said the company will contract research to the University as an extension of that pre-existing partnership.
However, Tandon also emphasized that the start-up needs to develop autonomy.
“It's really important that EpiBone builds its own know-how,” Tandon said.