Stem Cell TransplantationPhase 1/2NCT00713934
Autologous Bone Marrow Stem Cells in Cirrhosis Patients
A Phase 1/2 study testing CD133 and BM-MNC in people with Stem Cell Transplantation and Cirrhosis, run by Royan Institute at 2 sites in Iran.
Trial summary
Liver cirrhosis (LC) is the end stage of chronic liver disease. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it's serious problems. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stem Cell Transplantation, Cirrhosis
- What is being tested?
- CD133 and BM-MNC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesIran
- Study dates
- Jan 2008to Feb 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver biopsy showing histological Cirrhosis, grade B or C (Child-Pugh score)
- Alkaline phosphatase between 2 X to 3X normal value
- liver Cirrhosis in Sonography study
- Incomplete response to UDCA after 6 months of treatment.
- Negative pregnancy test (female patients in fertile age)
- written consent
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
- sepsis
- Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
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- HIV, HBV or HCV infection
- Cardiac, renal or respiratory failure
- Active thrombosis of the portal or hepatic veins
- INR>2
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Liver Transplant Research Center
Shiraz, Fars
Royan Institute
Tehran, Tehran Province, 1665659911
About this study
Official title: Autologous Transplantation of Bone Marrow Derived CD 133 Positive Stem Cell and Mono Nuclear Cell (MNC) Transplantation in Patients With Decompensate Cirrhosis: Randomized Clinical Trial
Liver cirrhosis (LC) is the end stage of chronic liver disease. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it's serious problems. The potential for stem cells in bone marrow (BM) to differentiate into hepatocytes cells was recently confirmed. Moreover, BMC transplantation has been performed to treat hematological diseases, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study we will evaluate safety and feasibility of autologous bone marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell transplantation through the portal vein in patients with decompensate cirrhosis.
Read the detailed description
BM (200 ml) will be harvested from the iliac crest according to standard procedures under general anesthesia and is collected in plastic bags containing anti coagulant. After precipitation of red blood cells, Low density mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For CD133+ cells separation the CliniMACS instrument will be used. Cells are injected via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 4 weeks, and laboratory data are analyzed for 24 weeks.
- Conditions
- Stem Cell Transplantation, Cirrhosis
- Being tested
- CD133, BM-MNC
- Keywords
- Autologous Bone marrow stem cells, Cirrhosis
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD133Biological
portal vein infusion of CD133+ cells
BM-MNCBiological
portal vein infusion of BM-MNC
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: CD133 |
| 2 | Experimental | Not described Receives: Biological: BM-MNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver function test
Measured: 6 months
MELD score
Measured: 6 months
Secondary outcomes (1)
Cirrhosis mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionFeb 2009
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 Stem Cell TransplantationStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Collaborators
- Small Business Developing Center, Shiraz University of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Hamid Gorabi, PhD, Study chair, Royan institute, Tehran, IranMalekhosseini, MD, Study chair, Liver Transplantation Research Center, Shiraz, IranHossein Baharvand, PhD, Principal investigator, Royan institute, Tehran, IranSaman Nikeghbal, MD, Principal investigator, Liver Transplantation Research Center, Shiraz, IranNasser Aghdami, MD, PhD, Study director, Royan institute, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713934
- Sponsor's protocol ID
- Liver-001
- Status last verified
- Mar 2010
- First submitted
- 9 Jul 2008
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nikeghbalian S, Pournasr B, Aghdami N, Rasekhi A, Geramizadeh B, Hosseini Asl SM, Ramzi M, Kakaei F, Namiri M, Malekzadeh R, Vosough Dizaj A, Malek-Hosseini SA, Baharvand H. Autologous transplantation of bone marrow-derived mononuclear and CD133(+) cells in patients with decompensated cirrhosis. Arch Iran Med. 2011 Jan;14(1):12-7.
PubMed 21194255
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Transplantation of Bone Marrow Derived CD 133 Positive Stem Cell and Mono Nuclear Cell (MNC) Transplantation in Patients With Decompensate Cirrhosis: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00713934
- Acronym / sponsor ID
- Liver-001
- Conditions
- Stem Cell Transplantation, Cirrhosis
- Keywords
- Autologous Bone marrow stem cells, Cirrhosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Collaborators
- Small Business Developing Center, Shiraz University of Medical Sciences
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 14 Jul 2008 (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.
Liver cirrhosis (LC) is the end stage of chronic liver disease. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it's serious problems. The potential for stem cells in bone marrow (BM) to differentiate into hepatocytes cells was recently confirmed. Moreover, BMC transplantation has been performed to treat hematological diseases, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study we will evaluate safety and feasibility of autologous bone marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell transplantation through the portal vein in patients with decompensate cirrhosis.
Detailed description
BM (200 ml) will be harvested from the iliac crest according to standard procedures under general anesthesia and is collected in plastic bags containing anti coagulant. After precipitation of red blood cells, Low density mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For CD133+ cells separation the CliniMACS instrument will be used. Cells are injected via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 4 weeks, and laboratory data are analyzed for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: CD133 |
| 2 | Experimental | Biological: BM-MNC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Liver biopsy showing histological Cirrhosis, grade B or C (Child-Pugh score)
- Alkaline phosphatase between 2 X to 3X normal value
- liver Cirrhosis in Sonography study
- Incomplete response to UDCA after 6 months of treatment.
- Negative pregnancy test (female patients in fertile age)
Key exclusion criteria (10 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
- sepsis
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 |
|---|---|---|
| CD133portal vein infusion of CD133+ cells | Biological | 1 |
| BM-MNCportal vein infusion of BM-MNC | Biological | 2 |
Primary outcome
Liver function test
Time frame: 6 months
MELD score
Time frame: 6 months
1 secondary outcome
Cirrhosis mortality
Time frame: 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 4 Oct 2011.
- Derived from this study: PubMed 21194255Nikeghbalian S, Pournasr B, Aghdami N, Rasekhi A, Geramizadeh B, Hosseini Asl SM, Ramzi M, Kakaei F, Namiri M, Malekzadeh R, Vosough Dizaj A, Malek-Hosseini SA, Baharvand H. Autologous transplantation of bone marrow-derived mononuclear and CD133(+) cells in patients with decompensated cirrhosis. Arch Iran Med. 2011 Jan;14(1):12-7.
- Royan InstituteLink provided by the sponsor.
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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.
Hamid Gorabi, PhD study chair
Royan institute, Tehran, Iran
Malekhosseini, MD study chair
Liver Transplantation Research Center, Shiraz, Iran
Hossein Baharvand, PhD principal investigator
Royan institute, Tehran, Iran
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 CD133 and BM-MNC in people with Stem Cell Transplantation and Cirrhosis, run by Royan Institute 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 6 inclusion and 10 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 4 Oct 2011. 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 (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT00713934, 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 4 Oct 2011.