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

NCT03963921 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-10-14

No results posted yet for this study

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

DRUG

HepaStem

Heterologous human adult liver-derived progenitor cells

Sponsors & Collaborators

  • Cellaion SA

    lead INDUSTRY

Principal Investigators

  • Etienne SOKAL, MD, PhD · CSMO

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-09
Primary Completion
2020-05-28
Completion
2020-08-31

Countries

  • Belgium
  • Bulgaria
  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03963921 on ClinicalTrials.gov