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Bone marrow stem cell transplantation in patients with decompensated liver cirrhosis

Autologous bone marrow stem cell transplantation in patients with decompensated liver cirrhosis: results from first in man study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16139487
Enrollment
34
Registered
2015-04-15
Start date
2011-02-10
Completion date
Unknown
Last updated
2015-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decompensated liver cirrhosis Digestive System Chronic Liver Disease/Cirrhosis

Interventions

1. 50-100 mL of bone marrow was aspirated from the anterior iliac crest under local anesthesia 2. At least 100 million of enriched mononuclear cells was infused into the hepatic artery of the patient

Sponsors

N. Kipshidze Central University Hospital (Georgia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Chronic hepatic failure 2. Ultrasonographic evidences of cirrhosis and portal hypertension 3. Child-Pough class B and C score 4. Patients must have the ability to sign the informed consent

Exclusion criteria

Exclusion criteria: 1. Patients aged less than 18 or more than 70 2. Hepatopulmonary syndrome 3. Documented hepatocellular carcinoma or history of other cancer 4. Presence of hepatic, portal or splenic vein thrombosis on doppler ultrasonography 5. History of autoimmune diseases 6. Use of hepatotoxic drugs within the last 6 month before enrolment 7. Decompensated heart failure 8. Renal failure (creatinine >2.5 mg/dL) 9. International normalized ratio (INR) >2.2 10. Patients with acute infection 11. Patients with pregnancy or lactation 12. Patients with recurrent gastrointestinal bleeding 13. Patients with spontaneous bacterial peritonitis 14. Patients unable to give informed consent

Design outcomes

Primary

MeasureTime frame
1. Liver function (blood) test 2. Model for End-Stage Liver Disease (MELD) score 3. Child-Pugh Score for cirrhosis mortality

Secondary

MeasureTime frame
Cirrhosis mortality

Countries

Georgia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026