Hepatocellular Carcinoma in Hepatitis C Virus Infected PatientsNCT01729221
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.
An observational study of Hepatocellular Carcinoma in Hepatitis C Virus Infected Patients, run by Cairo University at 1 site in Egypt.
Trial summary
Prospective study to calculated the incidence of hepatocellular carcinoma in hepatitis C virus infected patients after stem cell therapy. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma in Hepatitis C Virus Infected Patients
- How many people
- 280 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatitis C virus infected patients indicated for stem cell therapy
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Prospective study to calculated the incidence of hepatocellular carcinoma in hepatitis C virus infected patients after stem cell therapy.
Read the detailed description
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.
- Keywords
- Hepatocellular carcinoma, Hepatitis C virus
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCV infected patients treated by stem cell therap | Hepatitis C virus infected patients treated by stem cell therapy | |
| HCV infected patients treated by standared line of care | Hepatitis C virus infected patients treated by standared line of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hepatocellular carcinoma post stem cell therapy in hepatitis C virus infected patients
Measured: within the first year after stem cell therapy
Secondary outcomes (1)
Compare the incidence of hepatocellular carcinoma in patients who had received stem cell therapy to those who had received the standared line of care
Measured: within one year of follow up of hepatitis C virus infected patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startJan 2010
- Primary completionFeb 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma in Hepatitis C Virus Infected PatientsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekri AR, Cairo University
- Investigators
- Zekri Abdelrahman, M.SC, Ph,D, Study chair, National Cancer Institute , Cairo UniversityHosny Salama, M.D., Study director, Cairo UniversityZekri Abdelrahman, M.SC, Ph,D, Principal investigator, National Cancer Institute, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729221
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2012
- First submitted
- 17 Nov 2012
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24886681
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01729221
- Acronym / sponsor ID
- 1
- Keywords
- Hepatocellular carcinoma, Hepatitis C virus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective study to calculated the incidence of hepatocellular carcinoma in hepatitis C virus infected patients after stem cell therapy.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV infected patients treated by stem cell therap | – | –Hepatitis C virus infected patients treated by stem cell therapy |
| HCV infected patients treated by standared line of care | – | –Hepatitis C virus infected patients treated by standared line of care |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatitis C virus infected patients indicated for stem cell therapy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of hepatocellular carcinoma post stem cell therapy in hepatitis C virus infected patients
Time frame: within the first year after stem cell therapy
1 secondary outcome
Compare the incidence of hepatocellular carcinoma in patients who had received stem cell therapy to those who had received the standared line of care
Time frame: within one year of follow up of hepatitis C virus infected patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
- Derived from this study: PubMed 24886681Salama 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zekri Abdelrahman, M.SC, Ph,D study chair
National Cancer Institute , Cairo University
Hosny Salama, M.D. study director
Cairo University
Zekri Abdelrahman, M.SC, Ph,D principal investigator
National Cancer Institute, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma in Hepatitis C Virus Infected Patients, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hepatocellular carcinoma post stem cell therapy in hepatitis C virus infected patients (time frame: within the first year after stem cell therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01729221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.