NCT03963921

Safety and Tolerability of HepaStem in Patients With Cirrhotic and Pre-cirrhotic NASH Patients

Multicenter, Open-label, Safety and Tolerability Study of Ascending Doses of HepaStem in Patients With Cirrhotic and Pre-cirrhotic Non-alcoholic Steato-hepatitis (NASH)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Cellaion SA · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, open-label, safety and tolerability study of ascending doses of HepaStem in patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH) to determine the safety and tolerability of ascending single and repeated doses of HepaStem administered to patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH)

Conditions

• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	HepaStem	Heterologous human adult liver-derived progenitor cells

Timeline

• Start date: 2019-04-09
• Primary completion: 2020-05-28
• Completion: 2020-08-31
• First posted: 2019-05-28
• Last updated: 2020-10-14

Locations

13 sites across 4 countries: Belgium, Bulgaria, France, Spain