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This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | This arm will receive standard protocol of care alone | |
| Stem cells high dose | Experimental | This arm will receive high dose of Allogeneic Mesenchymal Stem Cells |
|
| Stem cells intermediate dose | Experimental | This arm will receive intermediate dose of Allogeneic Mesenchymal Stem Cells |
|
| Stem cells low dose | Experimental | This arm will receive low dose of Allogeneic Mesenchymal Stem Cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Mesenchymal Stem Cells | Biological | High dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | The type of adverse events, number of adverse events and proportion of patients with adverse events | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function tests. | To assess the improvement in liver function | 2 years |
| CT scan of abdomen. | To assess the improvement in liver structure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. BV Tantry, MD., DM | KMC, Mangalore | Principal Investigator |
| Dr. Samir Shah, MD., DM | Breach Candy Hospital, Mumbai | Principal Investigator |
| Dr. Dinesh Kini, MD., DM | Manipal Hospital, India | Principal Investigator |
| Dr.Deepak N Amarapuraka, MD., DM | Bombay Hospital & Medical Research Center, Mumbai | Principal Investigator |
| Dr. VA Saraswat, MD., DM | SGPGI, Kucknow | Principal Investigator |
| Dr. Aejaz Habeeb, MD., DM | Centre for Liver Research & Diagnostics, Hyderabad | Principal Investigator |
| Dr Uma Devi, MD | Mediciti Hospital | Principal Investigator |
| Dr Sanjay Kolte Kolte, DNB., FCPS | Sahyadri Speciality Hospital | Principal Investigator |
| Dr Sandeep Nijhwan Nijhwan, MD., DM | SMS Medical College and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Liver Research & Diagnostics | Hyderabad | Andhra Pradesh | 500058 | India | ||
| Mediciti Hospital |
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| Allogeneic Mesenchymal Stem Cells | Biological | Intermediate dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery |
|
| Allogeneic Mesenchymal Stem Cells | Biological | Low dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery |
|
| 2 years |
| Change in MELD score | To assess the clinical improvement | 2 years |
| Improvement in quality of life as assessed by SF 36 questionnaire | To assess the improvement in quality of life | 2 years |
| Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA | To assess the improvement in histopathology | 6 Months |
| Change in Child-Pugh score | To assess clinical improvement | 2 years |
| Dr. Nitin Pai, MD., DM | Ruby Hall clinic | Principal Investigator |
| Hyderabad |
| Andhra Pradesh |
| 500063 |
| India |
| Manipal Hospital | Bangalore | Karnataka | 560017 | India |
| KMC Hospital | Mangalore | Karnataka | 575001 | India |
| Institute of liver disease, HPB surgery and transplant Global Hospitals | Mumbai | Maharashtra | 400012 | India |
| Bombay Hospital & Medical Research Center | Mumbai | Maharashtra | 400020 | India |
| Ruby Hall clinic | Pune | Maharashtra | 411001 | India |
| Sahyadri Speciality Hospital | Pune | Maharashtra | 411004 | India |
| SMS Medical college and Hospital | Jaipur | Rajasthan | 302004 | India |
| SGPGI Lucknow | Lucknow | Uttar Pradesh | 226014 | India |
| ID | Term |
|---|---|
| D008104 | Liver Cirrhosis, Alcoholic |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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