Session Details

Plenary Session 1 – Mesenchymal and Progenitor Stem Cells: Results from the Clinic and the Future of Living Drugs
Friday, September 13, 2019 08:45 AM - 10:15 AM
Plenary Hall
Mesenchymal and Progenitor Stem Cells have begun to show clear evidence of efficacy outstanding safety profile in early clinical trials. This session aims to bring together some of those trials that are in the most advanced stages of testing. The presenters will each highlight the results from their efforts to with an emphasis on the lessons learned from these trials and their approach toward answering critical questions for the future of these technologies including purity, potency and logistics considerations.

Chair: Allan Dietz, PhD, Mayo Clinic, USA

Speakers:
Donna Skerrett, MD, MS, Mesoblast, USA

Addressing Major Areas of Unmet Medical Need with ""Off The Shelf"" Cell Therapy
Gil Van Bokkelen, PhD, Athersys, USA
Cell therapy has shown tremendous potential for addressing areas of substantial unmet medical need. The keys to unlocking this potential include achieving true scalability, demonstration of consistent safety and efficacy, and a corresponding understanding of key mechanisms of action. MultiStem represents a proprietary investigational allogeneic cell therapy that has shown promise in treating multiple critical care indications where current standard of care is limited or unavailable to many patients. Example indications where promising clinical results have been generated include the treatment of ischemic stroke (currently in Phase 3 with Fast Track and RMAT designations), acute respiratory distress syndrome (ARDS - also with Fast Track designation) and other indications.

Human Allogeneic Liver Progenitor Cells (HALPC) (HepasStem®) clinical development for Acute on Chronic Liver Failure and NASH
Etienne Sokal, MD, PhD, Promethera Université Catholique de Louvain, Institut de Recherche Clinique et Expérimentale (IREC), Laboratory of Pediatric Hepatology and Cell Therapy, Belgium
Progenitor Cells (HALPC) (HepasStem®, Promethera BiosciencesBsc, Mont-Saint-GuibertMt St Guibert, Belgium) have a specific well defined anti-inflammatory activity anti inflammatory activity mediated by PGE2 and HGF. They home to the liver and do not express HLA class II proteins. Preclinical models confirm anti-inflammatory and anti-fibrotic activities. In a phase IIa clinical trial, safety of ascending doses of Hepastem was demonstrated, and preliminary efficacy was shown on bilirubin, MELD and Child-Pugh score in Acute on Chronic Liver Failure. A large Phase II placebo randomized controlled trial is initiated. Phase I is also in progress in late stage NASH patients. Cells are delivered worldwide in dry shippers and given on site after simple reconstitution.