Vascular-degenerative diseases such as critical limb ischemia are on the rise in the United States, but the millions of people affected by these disorders worldwide have limited treatment options and no cures. An regenerative medicine startup spun out of Indiana University called Vascugen is seeking to change that.
Indianapolis-based Vascugen has licensed technology developed at the IU School of Medicine by its co-founder, Mervin Yoder, that pertains to using adult stem cells to form new blood vessels, says CEO Carter Cliff. Vascugen intends to use the licensed technology to devise therapies to repair tissue damaged by reduced blood flow due to disease or injury.
“It’s underappreciated how severe of an unmet need this is,” Cliff maintains. “[Vascular diseases] dramatically affect a patient’s quality of life.”
Cliff says Yoder’s lab was the first to discover rare cells that are responsible for the formation of new blood vessels in the body. It has also developed methods for manufacturing those cells. Vascugen can harvest adult stem cells and “reprogram” them to behave like embryonic stem cells; these reprogrammed cells are called induced pluripotent stem cells (IPSC) and they can be “coaxed into” producing a variety of different cell lines.
“We’ve identified methods for differentiating IPSC into target cell types,” Cliff says. “That’s the basis of our intellectual property. It’s possible to produce any cell type in the body from IPSC, and our product is a blood vessel-forming vascular progenitor to repair and maintain a patient’s vasculature.”
According to the National Heart, Lung, and Blood Institute, one in 20 Americans older than age 50 has peripheral artery disease, or PAD, often as a result of smoking or diabetes. Usually referred to as a “hardening of the arteries,” PAD develops when excess cholesterol in the bloodstream collects along the walls of arteries. Over time, this buildup reduces or stops blood flow and is the leading cause of limb amputations.
“Eventually, the body has reduced or exhausted its ability to maintain vasculature,” Cliff says. Once it hits that point, he adds, patients have essentially no treatment options. “If we can reintroduce blood flow, that may prevent the need for amputation,” he adds.
Cliff, who has co-founded a number of regenerative and precision medicine startups in Wisconsin, estimates there are up to two million patients in the U.S. alone “with completely unmet treatment needs.” Vascugen plans to initially target end-stage PAD patients who have no options. “If we’re effective there, we’ll look to prevent the condition earlier,” he says.
So far, the company’s approach has been shown it can work in mouse studies, Cliff says, but Vascugen is focused on doing more preclinical research to refine its treatment. In the next year or two, he says, the team will scale up and embark on “definitive animal studies” before proceeding to tests in humans.
The 10-person company will soon seek “a substantial venture capital investment” to carry it through clinical testing, Cliff says.
