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the study includes patients with liver cirrhosis irrespective of the stage excluding people with active tumor or other major health issue endangering life, the protocol includes the use of autologous bone marrow derived mononuclear cells harvested from the same patient under local anesthesia ,followed by cell concentration and viability testing , then final product is combined with small volume of 2 cc of Wharton gel exosomes 20 billion per to be administered intravenously.
Mesenchymal stem cell therapy is one option that can help in improving liver functions if given parenteral, those mesenchymal stem cells can be harvested from different sources ,regarding this trial investigators use bone marrow derived mononuclear cells taken from posterior crest of iliac bone of the same patient, the bone marrow volume taken is around 50 cubic milliliter to be followed by filtration to get rid of bone fragments then Wharton gel exosomes are added in 2 cc volume and total 20 billion particles ,the product is administered intravenously .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active treatment cellular product arm | Active Comparator | autologous bone marrow aspiration is done under sedation with the addition of Wharton gel 2 cc exosomes then given intravenously after using 170 micron filter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Bone Marrow Aspirate Concentrate | Procedure | using autologous bone marrow aspirated from iliac crest ,centrifuged and then injected intravenously |
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| Measure | Description | Time Frame |
|---|---|---|
| child-Pugh score for liver cirrhosis | The Child-Pugh score is a clinical tool used to assess the severity and prognosis of chronic liver disease, especially cirrhosis, by evaluating five key factors: total bilirubin, albumin, INR (prothrombin time), ascites, and hepatic encephalopathy, with each getting 1-3 points (1=best, 3=worst). Summing these points categorizes patients into Class A (5-6 points, well-compensated), B (7-9 points, moderately impaired), or C (10-15 points, severe dysfunction), helping guide treatment, predict surgical risk, and manage liver transplant needs. A is minimum and C maximum | 12 weeks up to 12 months |
| child-Pugh score of 3 stages depends on bilirubin level, serum albumin ,prothrombin time ,ascites ,encephalopathy | measurement of prothrombin time, albumin, serum bilirubin level and assess ascites and hepatic encephalopathy | 12 months |
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Inclusion Criteria: any patient with liver cirrhosis , less than 80 years of age -
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| abdulmajeed hammadi | Contact | +9647902268105 | hammadimajeed@gmail.com | |
| khalil juma kareem kareem | Contact | +9647803977072 | hammadimajeed@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Private Hospital Alrabee Street | Baghdad | Iraq | 964 | Iraq |
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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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10 cases liver cirrhosis regardless of the stage to be treated with autologous cells
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| D013568 |
| Pathological Conditions, Signs and Symptoms |