Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

April 24, 2014 updated by: Royan Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MNC
Bone marrow derived MNC
Biological: MNC
2-3 X 109 cells in 20ML suspension IPV in 4 min
EXPERIMENTAL: CD133
CD133 derived from Bone marrow
Biological: CD133
5-15 X 106 cells in 20ML suspension IPV
PLACEBO_COMPARATOR: Control
Normal saline with 5% Human Serum Albumin
Biological: Control
Injection of 20 ml Normal saline via IPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver function test
Time Frame: 6 months
Meld score, Child score
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cirrhosis Mortality
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Collaborators

University of Tehran

Investigators

  • Study Chair: Reza Malekzadeh, MD, Gastroenterology and hepatic disease research center
  • Principal Investigator: Mohammad Bagheri, MD, Gastroenterology and hepatic disease research center
  • Study Director: Massoud Vosough, MD, Royan Institute
  • Principal Investigator: Nasser Aghdami, MD., PhD, Royan Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

May 8, 2010

First Submitted That Met QC Criteria

May 8, 2010

First Posted (ESTIMATE)

May 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan-Liver-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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