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Autologous Bone Marrow Stem Cells in Cirrhosis Patients

NCT ID: NCT00713934

Last Updated: 2011-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-02-28

Brief Summary

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Liver cirrhosis (LC) is the end stage of chronic liver disease. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it's serious problems. The potential for stem cells in bone marrow (BM) to differentiate into hepatocytes cells was recently confirmed. Moreover, BMC transplantation has been performed to treat hematological diseases, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study we will evaluate safety and feasibility of autologous bone marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell transplantation through the portal vein in patients with decompensate cirrhosis.

Detailed Description

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BM (200 ml) will be harvested from the iliac crest according to standard procedures under general anesthesia and is collected in plastic bags containing anti coagulant. After precipitation of red blood cells, Low density mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For CD133+ cells separation the CliniMACS instrument will be used. Cells are injected via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 4 weeks, and laboratory data are analyzed for 24 weeks.

Conditions

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Stem Cell Transplantation Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

CD133

Intervention Type BIOLOGICAL

portal vein infusion of CD133+ cells

2

Group Type EXPERIMENTAL

BM-MNC

Intervention Type BIOLOGICAL

portal vein infusion of BM-MNC

Interventions

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CD133

portal vein infusion of CD133+ cells

Intervention Type BIOLOGICAL

BM-MNC

portal vein infusion of BM-MNC

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Liver biopsy showing histological Cirrhosis, grade B or C (Child-Pugh score)
* Alkaline phosphatase between 2 X to 3X normal value
* liver Cirrhosis in Sonography study
* Incomplete response to UDCA after 6 months of treatment.
* Negative pregnancy test (female patients in fertile age)
* written consent

Exclusion Criteria

* Presence of active hepatic encephalopathy
* Refractory ascites
* Evidences of active autoimmune liver disease (e.g. gamma globulin of more than 2 times of upper limit of normal, and ALT \> 3 times normal in patients with autoimmune hepatitis)
* Hepatocellular carcinoma or other malignancies
* sepsis
* Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
* HIV, HBV or HCV infection
* Cardiac, renal or respiratory failure
* Active thrombosis of the portal or hepatic veins
* INR\>2
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Small Business Developing Center

UNKNOWN

Sponsor Role collaborator

Shiraz University of Medical Sciences

OTHER

Sponsor Role collaborator

Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Gorabi, PhD

Role: STUDY_CHAIR

Royan institute, Tehran, Iran

Malekhosseini, MD

Role: STUDY_CHAIR

Liver Transplantation Research Center, Shiraz, Iran

Hossein Baharvand, PhD

Role: PRINCIPAL_INVESTIGATOR

Royan institute, Tehran, Iran

Saman Nikeghbal, MD

Role: PRINCIPAL_INVESTIGATOR

Liver Transplantation Research Center, Shiraz, Iran

Nasser Aghdami, MD, PhD

Role: STUDY_DIRECTOR

Royan institute, Tehran, Iran

Locations

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Liver Transplant Research Center

Shiraz, Fars, Iran

Site Status

Royan Institute

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

References

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Nikeghbalian S, Pournasr B, Aghdami N, Rasekhi A, Geramizadeh B, Hosseini Asl SM, Ramzi M, Kakaei F, Namiri M, Malekzadeh R, Vosough Dizaj A, Malek-Hosseini SA, Baharvand H. Autologous transplantation of bone marrow-derived mononuclear and CD133(+) cells in patients with decompensated cirrhosis. Arch Iran Med. 2011 Jan;14(1):12-7.

Reference Type DERIVED
PMID: 21194255 (View on PubMed)

Related Links

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http://www.royaninstitute.org

Royan Institute

Other Identifiers

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Liver-001

Identifier Type: -

Identifier Source: org_study_id