CirrhosisPhase 2NCT00476060
Mesenchymal Stem Cell Transplantation in Decompensated Cirrhosis
A Phase 2 study testing Autologous mesenchymal stem cell transplantation in people with Cirrhosis, run by University of Tehran at 1 site in Iran.
Trial summary
The standard treatment for decompensated cirrhosis is liver transplantation, however, it has several limitations. Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Autologous mesenchymal stem cell transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteIran
- Study dates
- Jan 2007to Aug 2011
- Phase
- Phase 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis (diagnosed by clinical, biochemical, sonographic, and histologic evidences of cirrhosis) (Patients will have histological documentation of cirrhosis before enrollment. However, for those with evidences of severe coagulopathy liver biopsy may not be performed)
- Evidences of decompensated liver disease at screening (e.g. child class B, or C)
Who cannot join
- 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
- Active infectious disease
- Presences of severe underlying cardiac, pulmonary, or renal disease
Show all 15Show fewer
- Alcohol use in the last 3 months before screening
- Use of hepatotoxic drugs in the last 3 months before screening
- Unwilling to assign the informed consent
- Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
- Positive HIV ab
- Positive HBsAg with detectable HBV DNA PCR
- Positive HCV Ab with detectable HCV RNA PCR
- Active thrombosis of the portal or hepatic veins
- Serum Cr > 1.8 mg/dL at screening
Trial locations and contacts
1 site in 1 country.
Iran1 site
Digestive Disease Research Center, Shariati Hospital
Tehran, 14117-13135
About this study
Official title: Autologous Mesenchymal Stem Cell Transplantation in Patients With Decompensated Cirrhosis: A Randomized Placebo-controlled Trial
The standard treatment for decompensated cirrhosis is liver transplantation, however, it has several limitations. Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis. The investigators have already completed the phase 1 study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find efficacy of this new treatment strategy in the setting of a multicenter, randomized placebo-controlled trial in 50 patients with decompensated cirrhosis.
Read the detailed description
The standard treatment for decompensated cirrhosis is liver transplantation, however, it has several limitations, including small donor pool, long waiting list, and several complications. Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis. The investigators have already completed the phase 1 study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find efficacy of this new treatment strategy in the setting of a multicenter, randomized placebo controlled trial. After assignment of the written informed consent, thirty six patients with decompensated cirrhosis will be enrolled, and will be randomized by block randomization into treatment or placebo arm. All the enrolled patients will be in the waiting list of liver transplantation. In the treatment arm bone marrow of the patients will be aspirated, and autologous bone marrow mesenchymal stem cells will be cultured, and then will be infused through a peripheral vein. Also, the corresponding placebo will be infused for the placebo group. The patients will be followed up for 1 year after performing the procedure.
- Conditions
- Cirrhosis
- Being tested
- Autologous mesenchymal stem cell transplantation
- Keywords
- Cirrhosis, Bone marrow, Mesenchymal stem cell, MELD score, Quality of life
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous mesenchymal stem cell transplantationProcedure or surgery
Arm A: 300 million cells will be infused one time through a peripheral vein/// Arm B: Infusion of placebo one time through a peripheral vein
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Procedure: Autologous mesenchymal stem cell transplantation |
| B | Placebo comparator | Not described Receives: Procedure: Autologous mesenchymal stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MELD score, quality of life, liver volume, histological improvement (In a subset of patients with evidences of clinical and biochemical improvement, follow up liver biopsy will be performed at the end of follow up).
Measured: One year
Secondary outcomes (1)
All cause mortality, tracking the infused cells in the patients' bodies.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tehran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Mohamadnejad, University of Tehran
- Investigators
- Reza Malekzadeh, M.D, Study chair, Digestive Disease Research Center, Medical Sciences/ University of TehranArdeshir Ghavamzadeh, M.D., Study chair, Hematology, Oncology, and BMT research center, Medical Sciences/University of TehranMehdi Mohamadnejad, M.D., Principal investigator, Digestive Disease Research Center, Medical Scineces/ University of TehranKamran Alimoghaddam, M.D., Principal investigator, Hematology, Oncology, and BMT research center, Medical Sciences/University of Tehran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476060
- Sponsor's protocol ID
- DDRC85-13
- Status last verified
- May 2023
- First submitted
- 16 May 2007
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Mesenchymal Stem Cell Transplantation in Patients With Decompensated Cirrhosis: A Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00476060
- Acronym / sponsor ID
- DDRC85-13
- Conditions
- Cirrhosis
- Keywords
- Cirrhosis, Bone marrow, Mesenchymal stem cell, MELD score, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of TehranUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 May 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 standard treatment for decompensated cirrhosis is liver transplantation, however, it has several limitations. Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis. The investigators have already completed the phase 1 study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find efficacy of this new treatment strategy in the setting of a multicenter, randomized placebo-controlled trial in 50 patients with decompensated cirrhosis.
Detailed description
The standard treatment for decompensated cirrhosis is liver transplantation, however, it has several limitations, including small donor pool, long waiting list, and several complications. Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis. The investigators have already completed the phase 1 study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find efficacy of this new treatment strategy in the setting of a multicenter, randomized placebo controlled trial. After assignment of the written informed consent, thirty six patients with decompensated cirrhosis will be enrolled, and will be randomized by block randomization into treatment or placebo arm. All the enrolled patients will be in the waiting list of liver transplantation. In the treatment arm bone marrow of the patients will be aspirated, and autologous bone marrow mesenchymal stem cells will be cultured, and then will be infused through a peripheral vein. Also, the corresponding placebo will be infused for the placebo group. The patients will be followed up for 1 year after performing the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Autologous mesenchymal stem cell transplantation |
| B | Placebo comparator | Procedure: Autologous mesenchymal stem cell transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cirrhosis (diagnosed by clinical, biochemical, sonographic, and histologic evidences of cirrhosis) (Patients will have histological documentation of cirrhosis before enrollment. However, for those with evidences of severe coagulopathy liver biopsy may not be performed)
- Evidences of decompensated liver disease at screening (e.g. child class B, or C)
Key exclusion criteria (15 listed)
- 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
- Active infectious disease
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 |
|---|---|---|
| Autologous mesenchymal stem cell transplantationArm A: 300 million cells will be infused one time through a peripheral vein/// Arm B: Infusion of placebo one time through a peripheral vein | Procedure or surgery | A, B |
Primary outcome
MELD score, quality of life, liver volume, histological improvement (In a subset of patients with evidences of clinical and biochemical improvement, follow up liver biopsy will be performed at the end of follow up).
Time frame: One year
1 secondary outcome
All cause mortality, tracking the infused cells in the patients' bodies.
Time frame: One year
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 16 May 2023.
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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.
Reza Malekzadeh, M.D study chair
Digestive Disease Research Center, Medical Sciences/ University of Tehran
Ardeshir Ghavamzadeh, M.D. study chair
Hematology, Oncology, and BMT research center, Medical Sciences/University of Tehran
Mehdi Mohamadnejad, M.D. principal investigator
Digestive Disease Research Center, Medical Scineces/ University of Tehran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous mesenchymal stem cell transplantation in people with Cirrhosis, run by University of Tehran at 1 site 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 2 inclusion and 15 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 16 May 2023. 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
MELD score, quality of life, liver volume, histological improvement (In a subset of patients with evidences of clinical and biochemical improvement, follow up liver biopsy will be performed at the end of follow up). (time frame: One year). 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 16 May 2023.