Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Small Business Developing Center | UNKNOWN |
| Shiraz University of Medical Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Liver cirrhosis (LC) is the end stage of chronic liver disease. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it's serious problems. The potential for stem cells in bone marrow (BM) to differentiate into hepatocytes cells was recently confirmed. Moreover, BMC transplantation has been performed to treat hematological diseases, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study we will evaluate safety and feasibility of autologous bone marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell transplantation through the portal vein in patients with decompensate cirrhosis.
BM (200 ml) will be harvested from the iliac crest according to standard procedures under general anesthesia and is collected in plastic bags containing anti coagulant. After precipitation of red blood cells, Low density mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For CD133+ cells separation the CliniMACS instrument will be used. Cells are injected via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 4 weeks, and laboratory data are analyzed for 24 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD133 | Biological | portal vein infusion of CD133+ cells |
| |
| BM-MNC |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function test | 6 months | |
| MELD score | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cirrhosis mortality | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hamid Gorabi, PhD | Royan institute, Tehran, Iran | Study Chair |
| Malekhosseini, MD | Liver Transplantation Research Center, Shiraz, Iran | Study Chair |
| Hossein Baharvand, PhD | Royan institute, Tehran, Iran | Principal Investigator |
| Saman Nikeghbal, MD | Liver Transplantation Research Center, Shiraz, Iran | Principal Investigator |
| Nasser Aghdami, MD, PhD | Royan institute, Tehran, Iran | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver Transplant Research Center | Shiraz | Fars | Iran | |||
| Royan Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21194255 | Derived | Nikeghbalian S, Pournasr B, Aghdami N, Rasekhi A, Geramizadeh B, Hosseini Asl SM, Ramzi M, Kakaei F, Namiri M, Malekzadeh R, Vosough Dizaj A, Malek-Hosseini SA, Baharvand H. Autologous transplantation of bone marrow-derived mononuclear and CD133(+) cells in patients with decompensated cirrhosis. Arch Iran Med. 2011 Jan;14(1):12-7. |
| Label | URL |
|---|---|
| Royan Institute | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
portal vein infusion of BM-MNC |
|
| Tehran |
| Tehran Province |
| 1665659911 |
| Iran |