Liver FailurePhase 1/2NCT00420134
Improvement of Liver Function in Liver Cirrhosis Patients After Autologous Mesenchymal Stem Cell Injection:a Phase I-II Clinical Trial
A Phase 1/2 study testing injection of progenitor of hepatocyte drived from Mesenchymal stem cell in people with Liver Failure and Cirrhosis, run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure, Cirrhosis
- What is being tested?
- injection of progenitor of hepatocyte drived from Mesenchymal stem cell
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 2 sitesIran
- Study dates
- Feb 2006to Jun 2009
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any evidence of hepatocellular carcinoma on liver ultrasound studies
- Patients want to exclude from study
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Research Center for Gastroenterology and Liver Diseases
Tehran, Tehran Province, 1985711151
Research center of Gastroenterology and Liver Disease
Tehran, Tehran Province, 1985711151
About this study
Official title: A Phase One/Two Clinical Trial on the Use of Autograft Mesenchymal Stem Cells Differentiated Into Progenitor of Hepatocytes for the Salvage Treatment of Patients With End-stage Liver Disease
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.
- Conditions
- Liver Failure, Cirrhosis
- Being tested
- injection of progenitor of hepatocyte drived from Mesenchymal stem cell
- Keywords
- mesenchymal stem cell, end stage liver disease, Cirrhosis, stem cell therapy
- Medical subject headings
- Liver Failure, Fibrosis, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of progenitor of hepatocyte drived from Mesenchymal stem cellProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver function test
MELD score
Secondary outcomes (1)
Cirrhosis mortality after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study startFeb 2006
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Tarbiat Modarres University
- Investigators
- Mohammad Reza Zali, MD, Study chair, Research center of Gastroenterology and Liver DiseasePedram Kharaziha, MD, Principal investigator, Research Center for Gastroenterology and Liver Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420134
- Sponsor's protocol ID
- 348
- Status last verified
- Sep 2009
- First submitted
- 8 Jan 2007
- Last updated
- 17 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase One/Two Clinical Trial on the Use of Autograft Mesenchymal Stem Cells Differentiated Into Progenitor of Hepatocytes for the Salvage Treatment of Patients With End-stage Liver Disease
- ClinicalTrials.gov ID
- NCT00420134
- Acronym / sponsor ID
- 348
- Conditions
- Liver Failure, Cirrhosis
- Keywords
- mesenchymal stem cell, end stage liver disease, Cirrhosis, stem cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Collaborators
- Tarbiat Modarres University
- Study start
- Feb 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Jan 2007 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Any evidence of hepatocellular carcinoma on liver ultrasound studies
- Patients want to exclude from study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of progenitor of hepatocyte drived from Mesenchymal stem cell | Procedure or surgery | – |
Primary outcome
Liver function test
MELD score
1 secondary outcome
Cirrhosis mortality after 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2009.
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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.
Mohammad Reza Zali, MD study chair
Research center of Gastroenterology and Liver Disease
Pedram Kharaziha, MD principal investigator
Research Center for Gastroenterology and Liver Diseases
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing injection of progenitor of hepatocyte drived from Mesenchymal stem cell in people with Liver Failure and Cirrhosis, run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 17 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Liver function test. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2009.