United Therapeutics announced positive results from its phase 1 study of miroliverELAP, an external liver assist product, in patients with acute forms of liver failure, acute-on-chronic liver failure, and severe acute alcoholic hepatitis, collectively called acute liver failure (ALF).
Developed by Miromatrix Medical, a wholly owned subsidiary of United Therapeutics, miroliverELAP consists of an external blood circuit and a single-use bioengineered liver sustained outside of the human body to provide temporary liver support to ALF patients. The bioengineered liver is manufactured by seeding a decellularized porcine liver scaffold with allogeneic human endothelial cells and human liver cells isolated from donated human livers. The donated human livers are not suitable for transplantation and are provided by organ procurement organizations (OPOs).
In the study, five ALF patients who were not candidates for a liver transplant were continuously treated with miroliverELAP for at least 44 hours. The single-arm, open label, safety study met the primary endpoint of survival during miroliverELAP treatment and there were no reports of unexpected serious adverse events attributable to the miroliverELAP over a subsequent 32-day follow-up period. Full study results will be presented and published in the second half of 2026.
“This study provides early evidence that miroliverELAP, an innovative bioengineered organ alternative product, has the potential to provide liver support for patients experiencing ALF, giving their native livers more time to recover. Achieving this important milestone allows us to continue advancing miroliverELAP to help save and improve the lives of ALF patients, who face poor outcomes and a desperate need for therapies,” said Jeff Ross, Ph.D., President of Miromatrix.
United Therapeutics’ organ and organ alternative manufacturing efforts consist of three platforms – xenotransplantation, allogeneic regenerative medicine, and autologous regenerative medicine – encompassing four different organs: hearts, kidneys, livers, and lungs. These programs are intended to address the ongoing shortage of transplantable organs for patients with end-stage organ disease.
Miromatrix received clearance from the United States Food and Drug Administration for its Investigational New Drug application for the phase 1 clinical trial of miroliverELAP in 2024. miroliverELAP is investigational and is not approved for any use in any country. In addition to miroliverELAP, Miromatrix is developing mirokidney, a fully transplantable bioengineered kidney, utilizing the same decellularization and seeding technology used in miroliverELAP.
