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Stem Cell Transplantation in Cirrhotic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02943889
Recruitment Status : Unknown
Verified October 2016 by Doaa Abdeltawab Abdellah, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : October 25, 2016
Last Update Posted : October 25, 2016
Information provided by (Responsible Party):
Doaa Abdeltawab Abdellah, Assiut University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Biological: Mesenchymal stem cell transplantation Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Bone-marrow Derived Stem Cell Transplantation in Patients With Decompensated Liver Cirrhosis: Clinical Trial
Study Start Date : October 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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.

Primary Outcome Measures :
  1. Improvement of liver function in form of improvement in child score [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Postpone or to overcome liver transplantation complications [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02943889

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Contact: Doaa Abdellah, MSc 00201003669941

Sponsors and Collaborators
Assiut University

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Responsible Party: Doaa Abdeltawab Abdellah, Dr, Assiut University Identifier: NCT02943889     History of Changes
Other Study ID Numbers: SCT-LC
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Doaa Abdeltawab Abdellah, Assiut University:
Mesenchymal stem cells
Liver cirrhosis
Stem cell therapy

Additional relevant MeSH terms:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases