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Application of the Stem Cell Therapy in the End Stage Liver Disease and Assessment Its Consequences in the Quality of Live Style as Well as Development of HCC.

NCT ID: NCT01729221

Last Updated: 2012-11-20

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

UNKNOWN

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-12-31

Brief Summary

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Prospective study to calculated the incidence of hepatocellular carcinoma in hepatitis C virus infected patients after stem cell therapy.

Detailed Description

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Our prospective research is carried out in one of the stem cell therapy centers in Egypt where 140 hepatitis C virus infected patients attending for stem cell therapy are enrolled in our study and the patients will be followed up after stem cell therapy where the incidence of hepatocellular carcinoma after stem cell therapy will be calculated , another group of hepatitis C virus infected patients attending to Kasr El Aini university hospital to receive the standered line of care as indicated will be enrolled in our study and will be followed up , where the incidence of hepatocellular carcinoma will be calculated and compared to the previous group , to determine if there is a significant difference between both groups regarding the incidence of hepatocellular and determine whether stem cell therapy affecets the incidence of hepatocellular carcinoma in hepatitis C virus infected patients.

Conditions

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Hepatocellular Carcinoma in Hepatitis C Virus Infected Patients

Keywords

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Hepatocellular carcinoma Hepatitis C virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HCV infected patients treated by stem cell therap

Hepatitis C virus infected patients treated by stem cell therapy

No interventions assigned to this group

HCV infected patients treated by standared line of care

Hepatitis C virus infected patients treated by standared line of care

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male or female patients aged from 20 to 65 years of age.
* Evidence of chronic liver insufficiency.
* The presence of decreased serum albumin and/or increased bilirubin and/or increased international normalized ratio (INR).
* Patient is unlikely to receive a liver transplant.
* Ability to give written consent
* Women of childbearing potential may be included, but must use a reliable and appropriate contraceptive method

Exclusion Criteria

* Patients below the age of 20 or above the age of 65 years
* Pregnant or lactating women
* Patients with recent recurrent GI bleeding or spontaneous bacterial peritonitis
* Patients with evidence of HIV or other life threatening infection
* Patients unable to give informed consent
* Patients with a history of hypersensitivity to G-CSF
* Patients who have been included in any other clinical trial within the previous month
* Patient with recurrent attacks of hepatic encephalopathy.
* Evedince of portal vein thrombosis by ultrasound.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Zekri AR

Proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zekri Abdelrahman, M.SC, Ph,D

Role: STUDY_CHAIR

National Cancer Institute , Cairo University

Hosny Salama, M.D.

Role: STUDY_DIRECTOR

Cairo University

Zekri Abdelrahman, M.SC, Ph,D

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Cairo University

Locations

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Cairo University & National Cancer Institute

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Salama H, Zekri AR, Medhat E, Al Alim SA, Ahmed OS, Bahnassy AA, Lotfy MM, Ahmed R, Musa S. Peripheral vein infusion of autologous mesenchymal stem cells in Egyptian HCV-positive patients with end-stage liver disease. Stem Cell Res Ther. 2014 May 28;5(3):70. doi: 10.1186/scrt459.

Reference Type DERIVED
PMID: 24886681 (View on PubMed)

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id