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| Name | Class |
|---|---|
| University of Tehran | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MNC | Experimental | Bone marrow derived MNC |
|
| CD133 | Experimental | CD133 derived from Bone marrow |
|
| Control | Placebo Comparator | Normal saline with 5% Human Serum Albumin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MNC | Biological | 2-3 X 109 cells in 20ML suspension IPV in 4 min |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function test | Meld score, Child score | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cirrhosis Mortality | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hamid Gourabi, PhD | Royan Institute | Study Chair |
| Reza Malekzadeh, MD | Gastroenterology and hepatic disease research center | Study Chair |
| Hossein Baharvand, PhD | Royan Institute | Principal Investigator |
| Mohammad Bagheri, MD | Gastroenterology and hepatic disease research center | Principal Investigator |
| Massoud Vosough, MD | Royan Institute | Study Director |
| Nasser Aghdami, MD., PhD | Royan Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology and hepatic disease research center | Tehran | Tehran Province | 14114 | Iran |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| CD133 |
| Biological |
5-15 X 106 cells in 20ML suspension IPV |
|
| Control | Biological | Injection of 20 ml Normal saline via IPV |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |