Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF (HEP101)

Cellaion

Status and phase: Completed; Phase 2

Conditions: Acute-On-Chronic Liver Failure

Treatments: Biological: HepaStem

Study type: Interventional

Funder types: Industry

Identifiers

NCT02946554

HEP101

Details and patient eligibility

About

The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Diagnosed cirrhosis
• Patient with Acute Decompensation of cirrhosis
• Serum total Bilirubin ≥ 6 mg/dL (≥100 umol/L)
• The INR measurement has to be : 1.2 ≤ INR < 2

Main Exclusion Criteria:

• Absence of portal vein flow
• Known or medical history of thrombotic events
• Gastrointestinal hemorrhage requiring blood transfusion
• Variceal bading or sclerosis within 4 weeks before infusion
• Septic shock or non-controlled bacterial infection
• Clinical evidence of aspergilus infection.
• Circulatory failure
• Respiratory disordered
• Coagulation disorders defined as INR ≥ 2, Fibrinogen < 100 mg/dL or Platelets < 50.000/mm3
• MELD score > 30.
• Major invasive procedure within 4 weeks before infusion
• Previous organ transplantation and/or ongoing immunosuppressive treatments.
• Renal failure due to chronic kidney disease.
• Clinically significant left-right cardiac shunt.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Low dose cohort

Other group

Description:

Two dose regimens of HepaStem will be given, which differ in the amount of cells per infusion. The low dose regimen will be given to the first cohort (first 6 patients included in the study).

Treatment:

Biological: HepaStem

High dose cohort

Other group

Description:

The high dose regimen will be given to the second cohort after evaluation of the safety of the 1st cohort (stepwise approach)

Treatment:

Biological: HepaStem