Clinical trial studies potential of stem cell treatment for liver disease
A Belgian cellular therapy company has announced data from a phase 2a clinical trial of a therapy for an incurable liver condition.
Promethera Biosciences SA is working on a product called HepaStem that takes liver stem cells, expands them in the laboratory and gives them via IV to patients with a liver condition known as acute-on-chronic liver failure (ACLF). The stem cells migrate through the blood and settle in the liver, supporting regeneration.
Today, the only treatment for ACLF is a liver transplant. “Looks like the data is good and showing that the dosing protocol is safe,” said Scott Jones, Vice President, Scientific Affairs, at BioBridge Global.
“Preliminarily, the data is showing liver function improvement. Still early to say what the true effect is, but it looks very promising.”
No adverse actions were reported among the 17 patients in the clinical trial. In addition, researchers found the treatment has shown signs of effectiveness in three indicators of the severity of liver disease.
“The next stages of our development plan will be to conduct a larger trial in ACLF focusing on clinical efficacy to restore better liver function, and potentially decrease mortality and need for transplantation,” said Etienne Sokal, MD, PhD, Promethera’s Chief Scientific & Medical Officer, in a news release.
Jones noted that GenCure is ramping up their biomanufacturing capabilities so in the future they could possibly manufacture cells for this type of treatment.
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