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Effect of Mesenchymal stem cells in patients with decompensated cirrhosis

Bone marrow mesenchymal stem cells in acute-on-chronic liver failure grades 2 and 3: a phase I-II randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-8n8csf
Enrollment
Unknown
Registered
2020-08-26
Start date
2018-09-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrosis and cirrhosis of liver

Interventions

Experimental group: 4 patients with grades 2 and 3 acute-on-chronic liver failure who will receive bone marrow-derived mesenchymal stem cells associated with standard medical treatment. Control group:
Biological/vaccine

Sponsors

Hospital de Clínicas de Porto Alegre
Lead Sponsor
Hospital de Clínicas de Porto Alegre
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: fulfilling ACLF diagnostic criteria and ACLF grade 2 or 3

Exclusion criteria

Exclusion criteria: patient’s or family member’s refusal; (b) hepatocellular carcinoma (HCC); (c) formal contraindicationfor liver transplantation (e.g. advanced heart or pulmonary disease); (d) pregnancy and lactation; (e) previous liver transplantation; (f) HIV co-infection; (g) ACLF grade 1; (h) patients admitted for elective procedures; (i) renal chronic disease requiring dialysis.

Design outcomes

Primary

MeasureTime frame
Evaluate mortality in the period of 28 and 90 days, verified by means of the Kaplain-Meier curves, from the observation of a variation post-intervention;Assess adverse effects, verified through clinical changes and vital signs, based on the observation of a post-intervention variation

Secondary

MeasureTime frame
Evaluate liver function patterns (prothrombin time, bilirubins and albumin) and inflammatory markers (total leukocytes and C-reactive protein) in the pre- and post-infusions of mesenchymal stem cells compared to placebo

Countries

Brazil

Contacts

Public ContactFernando;Fernando Schacher;Schacher

Hospital de Clínicas de Porto Alegre;Hospital de Clínicas de Porto Alegre

f_schacher@hotmail.com;f_schacher@hotmail.com(51) 981958310;(55 51) 981958310

Outcome results

None listed

Source: REBEC (via WHO ICTRP)