Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF)

Phase 2

Terminated

• Conditions: Acute on Chronic Liver Failure
• Interventions: Drug: Placebo; Drug: HepaStem

• Registration Number: NCT04229901
• Lead Sponsor: Cellaion SA

Brief Summary

This is an interventional, double blind, randomized (2:1), and placebo-controlled study of 2 infusions of a 1 dose regimen of HepaStem in patients recently diagnosed (≤1 week) with ACLF grade 1 or 2 on top of Standard of Care (SoC), and for whom the diagnosis is not resolved on the day of infusion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-11
• Study First Posted: 2020-01-18
• Study Start: 2020-01-21
• Status Verified: 2024-05
• Primary Completion: 2024-05-10
• Study Completion: 2024-05-10
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

1. Are adults aged between 18 and 75 years old.
2. Have an initial diagnosis of ACLF at the investigational site.
3. Have ACLF grade 1 or 2 according to the EASL-CLIF Consortium definition.
4. Have a total bilirubin ≥ 5 mg/dL.
5. Are able to read, understand and give written informed consent.

Main

Exclusion Criteria

1. Have a MELD-Na score > 35.

2. Have underlying cirrhosis due to biliary disease.

3. Have underlying cirrhosis due to autoimmune hepatitis.

4. Have active bleeding at a non-compressible site or at a compressible site that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study.

5. Have received treatment for bleeding complications during the current hospitalization and has a persistent high risk for re-bleeding that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study.

6. Have a complete portal vein thrombosis.

7. Have coagulation disturbances defined as:

   • fibrinogen < 80 mg/dL
   • platelets < 50 x 10³/mm³

8. Are requiring chronic dialysis therapy.

9. Have had a cerebrovascular, myocardial, limb arterial thrombotic event, or history for both thrombotic and hemorrhagic cerebrovascular events within 12 months prior to the Screening and not considered stabilized by the investigator.

10. Have a previous history of myocardial infarction and/or cardiac failure, with an ejection fraction rate (EFR) ≤ 40%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients in the placebo arm will receive 2 infusions of placebo (i.v) (7 day interval)
HepaStem	HepaStem	Patients in the HepaStem arm will receive 2 infusions of HepaStem (i.v) at 1.0 million of cells/kg of total body weight (7 day interval)

Primary Outcome Measures

Name	Time	Method
Survival	Day 90	Whether the patients are still alive will be recorded up to Day 90. Time and reason of death will be recorded.

Secondary Outcome Measures

Name	Time	Method
Transplant-free survival with MELD-Na score < 15	Day 90
Liver transplant-free survival	Day 90
Transplant-free survival while free of ACLF	Day 90
Duration of overall hospitalization and hospitalization in ICU and non-ICU during the index hospitalization	up to Day 90

Trial Locations

Locations (47)

Medical University Of Vienna; 🇦🇹 Vienna, Austria

UZ Antwerpen; 🇧🇪 Antwerp, Belgium

CHU Brugmann; 🇧🇪 Brussels, Belgium

CHU Erasme; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

CHC MontLégia; 🇧🇪 Liège, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Woluwe-Saint-Lambert, Belgium

University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"; 🇧🇬 Pleven, Bulgaria

UMHAT Medica; 🇧🇬 Ruse, Bulgaria

Scroll for more (37 remaining)