Stem Cell Transplantation in Cirrhotic Patients

NCT02943889 | Unknown Phase 1 DMC

• 1 other identifier: SCT-LC
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Cirrhosis

Keywords

Mesenchymal stem cells; Liver cirrhosis; Stem cell therapy

Outcome Measures

Primary Outcomes (1)

• Improvement of liver function in form of improvement in child score

  6 months

Secondary Outcomes (1)

• Postpone or to overcome liver transplantation complications

  2 years

Study Arms (2)

Mesenchymal stem cell transplantation

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Mesenchymal stem cell transplantation BIOLOGICAL

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.

Mesenchymal stem cell transplantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Decompensated liver cirrhosis child class b or c

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Mesenchymal Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Central Study Contacts

Doaa Abdellah, MSc

CONTACT

00201003669941; doaaabdeltawab@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 25, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 25, 2016

Record last verified: 2016-10