NCT00420134

Brief Summary

The methods for separation of mesenchymal stem cell were established in 2001. These cells can differentiate to osteocytes, hepatocytes, chondrocytes, myocytes and etc,. In this study the investigators try to separate mesenchymal stem cell from end stage liver disease, then these cells will be differentiated to progenitor of hepatocytes, finally , the investigators injected these cells into portal vein under ultrasound guide. The investigators determine the effects of injected cells in reestablishment of liver function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2006

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 17, 2009

Status Verified

September 1, 2009

Enrollment Period

3.2 years

First QC Date

January 8, 2007

Last Update Submit

September 15, 2009

Conditions

Liver FailureCirrhosis

Keywords

mesenchymal stem cellend stage liver diseaseCirrhosisstem cell therapy

Outcome Measures

Primary Outcomes (2)

  • Liver function test

  • MELD score

Secondary Outcomes (1)

  • Cirrhosis mortality after 6 months

Interventions

injection of progenitor of hepatocyte drived from Mesenchymal stem cellPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MELD score of at least 10
  • Patent portal vein on color Doppler examination of the liver
  • Normal alpha-feto protein serum levels
  • Age more than 18
  • Filling inform consent by patients and first degree family members

You may not qualify if:

  • Any evidence of hepatocellular carcinoma on liver ultrasound studies
  • Patients want to exclude from study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Center for Gastroenterology and Liver Diseases

Tehran, Tehran Province, 1985711151, Iran

Location

Research center of Gastroenterology and Liver Disease

Tehran, Tehran Province, 1985711151, Iran

Location

MeSH Terms

Conditions

Liver FailureFibrosisEnd Stage Liver Disease

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohammad Reza Zali, MD

    Research center of Gastroenterology and Liver Disease

    STUDY CHAIR

  • Pedram Kharaziha, MD

    Research Center for Gastroenterology and Liver Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2007

First Posted

January 9, 2007

Study Start

February 1, 2006

Primary Completion

May 1, 2009

Study Completion

June 1, 2009

Last Updated

September 17, 2009

Record last verified: 2009-09

Locations

IR(2)