NCT01120925

Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

Comparison of Therapeutic Outcome of Twice Transplantation of CD133+ and MNC BM Derived Stem Cells in Cirrhotic Patients: Clinical Trial, Double Blind, Phase I/II

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Royan Institute · Other Government
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Liver cirrhosis (LC) is the final outcome for chronic liver diseases. The liver transplantation is the sole effective therapy available to these patients. However, limited number of donors, post surgical complications, immunological rejection, and financial consideration are it's crucial problems. The plasticity of stem cells in bone marrow (BM) to differentiate into Hepatocyte cells was recently confirmed, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study, the investigators will study safety and feasibility of twice transplantation of Autologous bone derived marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell through the portal vein in patients with decompensate cirrhosis.

Detailed description

BM Aspiration will be done twice (3months interval) from the iliac crest according to standard procedures under general anesthesia and is collected (200ML) in plastic bags containing anti coagulant. After precipitation of red blood cells, mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For separation of CD133+ cells the CliniMACS instrument will be used. Cells are injected twice (3months interval) via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 6 months, and laboratory data are analyzed for 6 months

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
BIOLOGICAL	MNC	2-3 X 109 cells in 20ML suspension IPV in 4 min
BIOLOGICAL	CD133	5-15 X 106 cells in 20ML suspension IPV
BIOLOGICAL	Control	Injection of 20 ml Normal saline via IPV

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2010-05-11
• Last updated: 2014-04-28

Locations

1 site across 1 country: Iran