Stem Cell Transplantation in Cirrhotic Patients

October 24, 2016 updated by: Doaa Abdeltawab Abdellah, Assiut University

The Role of Bone-marrow Derived Stem Cell Transplantation in Patients With Decompensated Liver Cirrhosis: Clinical Trial

Chronic liver disease end by liver cirrhosis and increases the risk of cancer development. Chronic liver disease in Egypt is recognized as a serious health problem affecting greater than (20 %) of the population, where the main cause is chronic infection.

Liver transplantation is still the standard treatment for advanced decompensated liver cirrhosis. However, this treatment is quite limited in clinical practice. Therefore there is a concerted effort around the world to develop regenerative and alternative therapies, so, stem cell-based therapies are emerging as new alternatives to liver transplantation for end-stage liver pathologies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study aimed to transplant autologous bone marrow derived mesenchymal stem cells to the patients with liver cirrhosis to assess liver tissue regeneration, efficacy and safety of stem cell therapy and finally to establish an alternative treatment modality to liver transplantation.

Medical treatment of liver cirrhosis (the last stage of the illness) is very difficult that leads to high morbidity and mortality rate. Liver transplantation is still the most effective treatment for the patients with liver cirrhosis, However, serious problems are accompanied with liver transplantation, donor shortage, long waiting list, high cost, risk of rejection, operative complications and complications related to immunosuppressive drugs.

"stem cells" are cells in the human body that are capable to renew themselves and differentiate to a diverse range of specialized cell types and can be differentiated to specialized cells in appropriate medias in the laboratory. In recent years, advances in stem cell biology, have made the prospect of tissue regeneration a potential clinical reality, and several studies have shown the great promise that stem cells hold for therapy. mesenchymal stem cell based therapy has shown as promising tool in cirrhotic conditions as this type of cells have the ability to differentiate to different cell types including hepatocytes A series of studies have been performed to assess the application of bone marrow derived mesenchymal stem cells to promote liver regeneration and to alleviate cirrhosis. Some animal-based studies showed that stem cell transplantation could ameliorate liver fibrosis and improve liver functions followed by several clinical trials on human, in patients with advanced liver diseases, these studies demonstrated that stem cell transplantation could significantly reverse hepatic failure with only limited side effects. However, the effectiveness of this therapy in recent clinical trials is still conflicting and need further evaluation.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Decompensated liver cirrhosis child class b or c

Exclusion Criteria:

  • Patients with portal vein thrombosis, or
  • Recent recurrent gastrointestinal bleeding, or
  • Hepatocellular carcinoma (HCC), or
  • Spontaneous bacterial peritonitis
  • Pregnant or lactating women
  • Vital organs failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesenchymal stem cell transplantation
This group will include 20 patients with liver cirrhosis, autologous bone marrow derived mesenchymal stem cells will be transplanted to them. Every patient will receive 2 million cells per Kg via portal vein once.
Biological: Mesenchymal stem cell transplantation
Bone marrow aspiration by clinical pathologist. Isolation, propagation and differentiation of stem cells will be done in stem cell center. After confirmation of the trans-differentiation into hepatocytes at the laboratory level, it will be infused into the portal vein under ultrasound guidance.
No Intervention: Control group
This group will include 20 patients with liver cirrhosis as control group matching (stem cell group) in age, sex and child score. They will continue on the conventional therapy they already on and no stem cell transplantation will done for them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of liver function in form of improvement in child score
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Postpone or to overcome liver transplantation complications
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCT-LC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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