Allogenic Bone Marrow Mesenchymal Stem Cell Therapy in Acute-on-chronic Liver Failure

NCT02857010 | Terminated Phase 1 DMC

• 1 other identifier: 2012-003900-11
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Double-blind placebo randomized controlled trial evaluating the clinical efficacy of allogenic bone marrow derived mesenchymal stem cells in cirrhotic patients with acute-on-chronic liver failure

Conditions

Acute on Chronic Hepatic Failure

Outcome Measures

Primary Outcomes (1)

• Change in organ function: chronic liver failure-sequential organ failure assessment (CLIF-SOFA)

  Change from Baseline CLIF-SOFA score at 28 days

Secondary Outcomes (16)

• Child-Pugh score as a marker of liver function

  Change from Baseline Child-Pugh score at 28 days, 90 days, one year and 2 years

• Model for End-stage Liver Disease (MELD) score as a marker of liver function

  Change from Baseline MELD score at 28 days, 90 days, one year and 2 years

• serum bile acids as a surrogate marker of liver function

  Change from Baseline serum bile acids at 28 days

• ammonia levels as a surrogate marker of liver function

  Change from Baseline serum ammonia at 7, 21 and 28 days

• Lactate levels as a surrogate marker of liver function

  Change from Baseline serum lactate levels at 7, 21 and 28 days

Study Arms (2)

Allogenic Mesenchymal stem cells

EXPERIMENTAL

Intravenous allogenic bone marrow derived mesenchymal stem cells: 4 doses of 2 x 106/kg administered on days 1, 4, 11 and 18

Biological: Allogenic mesenchymal stem cells

Placebo

PLACEBO COMPARATOR

Solution without cells on days 1, 4, 11 and 18

Other: Placebo

Interventions

Allogenic mesenchymal stem cells BIOLOGICAL

Cell therapy

Allogenic Mesenchymal stem cells

Placebo OTHER

Serum without stem cells

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver cirrhosis
• ACLF grade 1, 2 or 3 (Canonic criteria)
• Signed informed consent

You may not qualify if:

• Acute or subacute liver failure without cirrhosis
• ACLF grade 1 with response to medical therapy
• Evidence of current malignancy including hepatocellular carcinoma (any grade) or alphafetoprotein \> 400 ng/ml
• Previous personal history of malignancy (active or in complete remission) or familiar history of hereditary cancer.
• Moderate or severe chronic heart failure (NYHA III-IV)
• Renal replacement therapy
• Severe chronic pulmonary disease (GOLD III-IV)
• Gastrointestinal bleeding in the last 5 days
• Previous liver transplantation
• Immunosuppressive therapy
• Extrahepatic cholestasis
• HIV infection
• Pregnant of breastfeeding women
• Pre-menopausal women who are of child bearing potential and are not practicing an acceptable method of birth control.
• Participation in any investigational trial in the last 3 months

Sponsors & Collaborators

• Pere Gines: lead
• Clinica Universidad de Navarra, Universidad de Navarra: collaborator

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Study Officials

• Javier Fernandez, MD, PhD

  Hospital Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Liver Unit

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: August 5, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2020
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)