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NCT Number: NCT01120925

Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Gastroenterology and hepatic disease research center

Tehran, Tehran Province, 14114, Iran

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MNC

Biological

2-3 X 109 cells in 20ML suspension IPV in 4 min

CD133

Biological

5-15 X 106 cells in 20ML suspension IPV

Control

Biological

Injection of 20 ml Normal saline via IPV

Primary outcomes

  1. Liver function test

    Time frame: 6 months

    Meld score, Child score

Secondary outcomes

  1. Cirrhosis Mortality

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Collaborators

  • University of Tehran

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 11, 2010
Registry last updated
Apr 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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