An experimental liver-growing therapy is facing its biggest test yet for humans. This week, biotech company LyGenesis announced that it has just begun a Phase II trial of its therapy designed to grow mini-livers within people’s lymph nodes. If this therapy works as expected, it could potentially save the lives of many patients with life-threatening liver disease who are unable to obtain routine transplants.
The therapy is currently called LYG-LIV-001. It comes from donated livers that would otherwise not be matched to any potential transplant recipient. Certain cells called hepatocytes are collected from these livers and suspended in a solution. The cells are then transplanted into the recipient’s upper abdominal lymph nodes using a combination of minimally invasive surgery and endoscopic ultrasound. From there, the lymph nodes are expected to act as living “bioreactors” that help liver cells grow and mature into functional liver tissue if they are ectopic (outside their usual location in the body).
LyGenesis hopes LYG-LIV-001 will gain approval for treatment end stage liver disease, or ESLD, a state of severe chronic organ damage. Although people with ESLD can live for many years, it is estimated to be responsible for about 2% of deaths each year.Liver transplantation can be an effective treatment, but many people with the disease do not meet the criteria to be organ recipients, and about 17 percent are on the waiting list for a new liver die every year. Tuesday, LyGenesis report The first ESLD patient in the Phase II trial has now received LYG-LIV-001.
“By helping ESLD patients grow new functional ectopic livers in their own bodies, this therapy could become a significant milestone in regenerative medicine,” LyGenesis CEO Michael Hufford said in a statement. If our Successfully studied and approved by the FDA, our allogeneic cell therapy could enable a single donated liver to treat dozens of ESLD patients, which may help reverse the current imbalance between organ supply and demand in favor of patients. “
However, it will be several months before scientists know whether the treatment actually helped the first patient.The trial enrolled a total of 12 patients and did not expected to be completed Until early 2026. But if this research continues to show promise, the sky may be the limit. LyGenesis is also developing its bioreactor technology to grow other organs, including kidneys, thymus and pancreas.