Company Spotlight

LyGenesis Is Growing Organs in Lymph Nodes—and Rethinking the Future of Transplantation

With organ shortages claiming thousands of lives each year, LyGenesis is working to rewrite the rules of transplantation—by growing organs inside a patient’s own body.

The Pittsburgh-based company is pioneering a novel approach to cell therapy that use a patient’s lymph nodes as natural bioreactors to grow fully functioning organs within the body. Their lead program, now in a Phase 2a clinical trial, focuses on liver regeneration for patents with end stage liver disease. Instead of replacing a failing liver with a donor organ, LyGenesis injects donor liver cells into a lymph node using a minimally invasive endoscopic ultrasound procedure. Over time, the cells proliferate and form a miniature, working liver that supports the diseased organ.

“Instead of 1 liver being used to treat one patient, our lead program can treat up to 75 patients from a single donated liver,” says CEO Michael Hufford, PhD. “That completely transforms the supply-demand problem that’s plagued organ transplantation for decades.”

The science—developed by cofounder and chief scientific officer Eric Lagasse, PharmD. PhD, at the University of Pittsburgh—builds on a fascinating biological insight: lymph nodes, already optimized by evolution to grow immune cells, are fertile ground for tissue growth. This is a reason why cancer often metastasizes to them. LyGenesis redirects that innate growth capability toward organ regeneration. The result? A therapy that can be manufactured and administered in an outpatient setting for a small fraction of the cost of a traditional liver transplant.

The implications go far beyond cost. Half of all end-stage liver disease patients aren’t even eligible for the transplant list due to poor health and other comorbidities, says Hufford. But LyGenesis’s low-risk procedure, performed under light sedation, could offer these patients a second chance.

“We’re not just solving for scarcity—we’re solving for access,” says Hufford. “This therapy opens the door for patients who’ve historically been left with no viable options.”

LyGenesis draws strength from its Pittsburgh environment. The legacy of transplant pioneer Dr. Tom Starzl, along with affordable lab space, access to top-tier research at the University of Pittsburgh, and a steady pipeline of scientific talent have all played key roles in the company’s lean, capital-efficient growth. It has reached human trials with just under $40 million in investor funding—an impressive feat in the biotech sector.

“Pittsburgh has been the perfect place to build LyGenesis,” Hufford says. “We have deep medical expertise in transplantation, led by our cofounder and chief medical officer, Paulo Fontes, MD, FACS, world-class clinical partners, and the kind of collaborative, cost-effective ecosystem that lets us do serious science without burning through massive amounts of capital.”

While liver is first, it’s only the beginning. LyGenesis is also advancing programs in kidney, pancreas, and thymus regeneration—the latter with intriguing potential implications for immune function and aging.

Whether its therapies ultimately replace transplants or serve as a bridge to them, LyGenesis is changing the equation in regenerative medicine—with a scalable, accessible model that could bring lifesaving care to far more people.

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