Stem Cell Transplantation in Cirrhotic Patients

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02943889
• Other study ID #: SCT-LC
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: September 27, 2016
• Last updated: October 24, 2016
• Start date: October 2016
• Est. completion date: August 2017

Study information

• Verified date: October 2016
• Source: Assiut University
• Contact: Doaa Abdellah, MSc
• Phone: 00201003669941
• Email: doaaabdeltawab[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of liver function in form of improvement in child score		6 months	Yes
Secondary	Postpone or to overcome liver transplantation complications		2 years	Yes