Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Status: Unknown

Conditions: Liver Cirrhosis

Treatments: Genetic: autologous mesenchymal stem cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01499459

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1111111 (Other Identifier)

Details and patient eligibility

About

This study is aiming to investigate the efficacy of autologous mesenchymal stem cell (MSC) transplantation in 25 randomized patients with liver cirrhosis autologous mesenchymal stem cell will be derived from patients' bone marrows and will be infused via peripheral vein. Liver biopsies will be performed in every patient in the beginning and at 6th month.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• radiological, clinical and histopathological diagnosis of liver cirrhosis
• absence of hepatocellular carcinoma or any malignancies
• no psychiatric disorder
• no serous cardiovascular and pulmonary comorbidities
• serum total bilirubin levels less than 5 mg/dL
• platelet counts more than 30.000 mm3
• more than one year follow up period after initiation of antiviral drugs

Exclusion criteria

• alcohol intake in last one year
• initiation of antiviral medication in last one year
• systemic diseases

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

autologous mesenchymal stem cell transplantation

Experimental group

Treatment:

Genetic: autologous mesenchymal stem cell transplantation