Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

Study Overview
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Brief Summary
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Liver cirrhosis (LC) is the final outcome for chronic liver diseases. The liver transplantation is the sole effective therapy available to these patients. However, limited number of donors, post surgical complications, immunological rejection, and financial consideration are it's crucial problems. The plasticity of stem cells in bone marrow (BM) to differentiate into Hepatocyte cells was recently confirmed, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study, the investigators will study safety and feasibility of twice transplantation of Autologous bone derived marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell through the portal vein in patients with decompensate cirrhosis.

Detailed Description
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BM Aspiration will be done twice (3months interval) from the iliac crest according to standard procedures under general anesthesia and is collected (200ML) in plastic bags containing anti coagulant. After precipitation of red blood cells, mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For separation of CD133+ cells the CliniMACS instrument will be used. Cells are injected twice (3months interval) via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 6 months, and laboratory data are analyzed for 6 months

Official Title
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Comparison of Therapeutic Outcome of Twice Transplantation of CD133+ and MNC BM Derived Stem Cells in Cirrhotic Patients: Clinical Trial, Double Blind, Phase I/II

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Biological: MNC
* Biological: CD133
* Biological: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 16-65 Years cirrhotic patient Approved cirrhosis by elastografy ,biopsy, sonography Serum ALT 1/5 times more than normal MELD score 12 or Child score B or C Exclusion Criteria: Portal vein thrombosis Hepatic encephalopathy, score 3&4 ALT & AST 3times more than normal Serum Cr more than 1/5mg/dL (Anti-HIV +) (Anti-HCV+) (HBS-Ag+) Hepatocel carcinoma Primary sclerosing cholangitis (PSC) Esophageal varices grade 4 Addiction

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MNC<br>Bone marrow derived MNC | Biological: MNC<br>* 2-3 X 109 cells in 20ML suspension IPV in 4 min<br>|
| Experimental: CD133<br>CD133 derived from Bone marrow | Biological: CD133<br>* 5-15 X 106 cells in 20ML suspension IPV<br>|
| Placebo Comparator: Control<br>Normal saline with 5% Human Serum Albumin | Biological: Control<br>* Injection of 20 ml Normal saline via IPV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function test | Meld score, Child score | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cirrhosis Mortality |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cirrhotic, Stem Cells, Bone marrow stem cells, Decompensate Cirrhotic Patients