Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

Phase 1

Completed

• Conditions: Liver Cirrhosis
• Interventions: Biological: MNC; Biological: CD133; Biological: Control

• Registration Number: NCT01120925
• Lead Sponsor: Royan Institute

Brief 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

Study Timeline

• Status Verified: 2010-05
• Study Start: 2010-05
• Study First Submitted: 2010-05-08
• Study First Submitted QC: 2010-05-08
• Study First Posted: 2010-05-11
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 16-65 Years cirrhotic patient
• Approved cirrhosis by elastografy ,biopsy, sonography
• Serum ALT 1/5 times more than normal
• MELD score 12 or Child score B or C

Exclusion Criteria

• Portal vein thrombosis
• Hepatic encephalopathy, score 3&4
• ALT & AST 3times more than normal
• Serum Cr more than 1/5mg/dL
• (Anti-HIV +) (Anti-HCV+) (HBS-Ag+)
• Hepatocel carcinoma
• Primary sclerosing cholangitis (PSC)
• Esophageal varices grade 4
• Addiction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MNC	MNC	Bone marrow derived MNC
CD133	CD133	CD133 derived from Bone marrow
Control	Control	Normal saline with 5% Human Serum Albumin

Primary Outcome Measures

Name	Time	Method
Liver function test	6 months	Meld score, Child score

Secondary Outcome Measures

Name	Time	Method
Cirrhosis Mortality	6 months

Trial Locations

Locations (1)

Gastroenterology and hepatic disease research center; 🇮🇷 Tehran, Iran, Islamic Republic of