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Stem Cell Transplantation in Cirrhotic Patients

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02943889
Enrollment
40
Registered
2016-10-25
Start date
2016-10-31
Completion date
2017-08-31
Last updated
2016-10-25

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

Conditions

Liver Cirrhosis

Keywords

Mesenchymal stem cells, Liver cirrhosis, Stem cell therapy

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.

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.

Interventions

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
Improvement of liver function in form of improvement in child score6 months

Secondary

MeasureTime frame
Postpone or to overcome liver transplantation complications2 years

Contacts

Primary ContactDoaa Abdellah, MSc
doaaabdeltawab@gmail.com00201003669941

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026