Liver Cirrhosis
Conditions
Brief summary
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.
Detailed description
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 .
Interventions
using autologous bone marrow aspirated from iliac crest ,centrifuged and then injected intravenously
Sponsors
Global Stem Cell Center, Baghdad
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
10 cases liver cirrhosis regardless of the stage to be treated with autologous cells
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
Inclusion criteria
any patient with liver cirrhosis , less than 80 years of age -
Exclusion criteria
1. active malignancy. 2. severe sepsis. 3. pregnancy. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| child-Pugh score for liver cirrhosis | 12 weeks up to 12 months | 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 |
| child-Pugh score of 3 stages depends on bilirubin level, serum albumin ,prothrombin time ,ascites ,encephalopathy | 12 months | measurement of prothrombin time, albumin, serum bilirubin level and assess ascites and hepatic encephalopathy |
Countries
Iraq
Contacts
CONTACTabdulmajeed hammadi
CONTACTkhalil juma kareem kareem
Outcome results
None listed