Stem cell therapy for ACLF progresses to safety, efficacy trial
Promethera Biosciences started a phase 2b clinical trial on their product HepaStem. It is a therapy intended for patients with chronic liver failure.
“We are developing HepaStem as a treatment for ACLF at a fast pace and we are determined to bring it to patients in need as soon as we can,” Etienne Sokal, MD, PhD, founder and group chief medical officer of Promethera, said in the release. “As a potentially pivotal trial, the results obtained here may provide us with sufficient clinical data to file a new drug application.”
The success of this trial will guide researchers to test the product for patients with other liver conditions.
Researchers will test the therapy on 363 patients with grade 1 or grade 2 ACLF. Safety and efficacy are objectives of the trial. Practitioners will give patients two weekly intravenous infusions.
Researchers found that HepaStem was safe in patients that received injections. MELD, bilirubin levels, and Child-Pugh score were improved.
“ACLF is a severe, life threatening disease, with no current available treatments,” John Tchelingerian, PhD, president and CEO of the Promethera Group, said. “HepaStem has the potential to be the first real alternative to liver transplants in such a disease, and help ACLF patients in need.”