Liver CirrhosisPhase 1/2NCT01120925
Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients
A Phase 1/2 study testing MNC and CD133 in people with Liver Cirrhosis, run by Royan Institute at 1 site in Iran.
Trial summary
Liver cirrhosis (LC) is the final outcome for chronic liver diseases. The liver transplantation is the sole effective therapy available to these patients. However, limited number of donors, post surgical complications, immunological rejection, and financial consideration are it's crucial problems. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- MNC and CD133
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- May 2010to Jul 2013
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16-65 Years cirrhotic patient
- Approved cirrhosis by elastografy ,biopsy, sonography
- Serum ALT 1/5 times more than normal
- MELD score 12 or Child score B or C
Who cannot join
- Portal vein thrombosis
- Hepatic encephalopathy, score 3\&4
- ALT \& AST 3times more than normal
- Serum Cr more than 1/5mg/dL
- (Anti-HIV +) (Anti-HCV+) (HBS-Ag+)
- Hepatocel carcinoma
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- Primary sclerosing cholangitis (PSC)
- Esophageal varices grade 4
- Addiction
Trial locations and contacts
1 site in 1 country.
Iran1 site
Gastroenterology and hepatic disease research center
Tehran, Tehran Province, 14114
About this study
Official title: Comparison of Therapeutic Outcome of Twice Transplantation of CD133+ and MNC BM Derived Stem Cells in Cirrhotic Patients: Clinical Trial, Double Blind, Phase I/II
Liver cirrhosis (LC) is the final outcome for chronic liver diseases. The liver transplantation is the sole effective therapy available to these patients. However, limited number of donors, post surgical complications, immunological rejection, and financial consideration are it's crucial problems. The plasticity of stem cells in bone marrow (BM) to differentiate into Hepatocyte cells was recently confirmed, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study, the investigators will study safety and feasibility of twice transplantation of Autologous bone derived marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell through the portal vein in patients with decompensate cirrhosis.
Read the detailed description
BM Aspiration will be done twice (3months interval) from the iliac crest according to standard procedures under general anesthesia and is collected (200ML) in plastic bags containing anti coagulant. After precipitation of red blood cells, mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For separation of CD133+ cells the CliniMACS instrument will be used. Cells are injected twice (3months interval) via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 6 months, and laboratory data are analyzed for 6 months
- Conditions
- Liver Cirrhosis
- Being tested
- MNC, CD133, Control
- Keywords
- Cirrhotic, Stem Cells, Bone marrow stem cells, Decompensate Cirrhotic Patients
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNCBiological
2-3 X 109 cells in 20ML suspension IPV in 4 min
CD133Biological
5-15 X 106 cells in 20ML suspension IPV
ControlBiological
Injection of 20 ml Normal saline via IPV
| Study group | Role | What they receive |
|---|---|---|
| MNC | Experimental | Bone marrow derived MNC Receives: Biological: MNC |
| CD133 | Experimental | CD133 derived from Bone marrow Receives: Biological: CD133 |
| Control | Placebo comparator | Normal saline with 5% Human Serum Albumin Receives: Biological: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver function test
Meld score, Child 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 posted11 May 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Collaborators
- University of Tehran
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Royan InstituteReza Malekzadeh, MD, Study chair, Gastroenterology and hepatic disease research centerHossein Baharvand, PhD, Principal investigator, Royan InstituteMohammad Bagheri, MD, Principal investigator, Gastroenterology and hepatic disease research centerMassoud Vosough, MD, Study director, Royan InstituteNasser Aghdami, MD., PhD, Principal investigator, Royan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120925
- Sponsor's protocol ID
- Royan-Liver-002
- Status last verified
- May 2010
- First submitted
- 8 May 2010
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Therapeutic Outcome of Twice Transplantation of CD133+ and MNC BM Derived Stem Cells in Cirrhotic Patients: Clinical Trial, Double Blind, Phase I/II
- ClinicalTrials.gov ID
- NCT01120925
- Acronym / sponsor ID
- Royan-Liver-002
- Conditions
- Liver Cirrhosis
- Keywords
- Cirrhotic, Stem Cells, Bone marrow stem cells, Decompensate Cirrhotic Patients
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Collaborators
- University of Tehran
- Study start
- May 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 May 2010 (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 final outcome for chronic liver diseases. The liver transplantation is the sole effective therapy available to these patients. However, limited number of donors, post surgical complications, immunological rejection, and financial consideration are it's crucial problems. The plasticity of stem cells in bone marrow (BM) to differentiate into Hepatocyte cells was recently confirmed, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study, the investigators will study safety and feasibility of twice transplantation of Autologous bone derived marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell through the portal vein in patients with decompensate cirrhosis.
Detailed description
BM Aspiration will be done twice (3months interval) from the iliac crest according to standard procedures under general anesthesia and is collected (200ML) in plastic bags containing anti coagulant. After precipitation of red blood cells, mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For separation of CD133+ cells the CliniMACS instrument will be used. Cells are injected twice (3months interval) via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 6 months, and laboratory data are analyzed for 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MNC | Experimental | Biological: MNCBone marrow derived MNC |
| CD133 | Experimental | Biological: CD133CD133 derived from Bone marrow |
| Control | Placebo comparator | Biological: ControlNormal saline with 5% Human Serum Albumin |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 16-65 Years cirrhotic patient
- Approved cirrhosis by elastografy ,biopsy, sonography
- Serum ALT 1/5 times more than normal
- MELD score 12 or Child score B or C
Key exclusion criteria (9 listed)
- Portal vein thrombosis
- Hepatic encephalopathy, score 3\&4
- ALT \& AST 3times more than normal
- Serum Cr more than 1/5mg/dL
- (Anti-HIV +) (Anti-HCV+) (HBS-Ag+)
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 |
|---|---|---|
| MNC2-3 X 109 cells in 20ML suspension IPV in 4 min | Biological | MNC |
| CD1335-15 X 106 cells in 20ML suspension IPV | Biological | CD133 |
| ControlInjection of 20 ml Normal saline via IPV | Biological | Control |
Primary outcome
Liver function test
Time frame: 6 months
Meld score, Child score
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 28 Apr 2014.
- Related InfoLink 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 Gourabi, PhD study chair
Royan Institute
Reza Malekzadeh, MD study chair
Gastroenterology and hepatic disease research center
Hossein Baharvand, PhD principal investigator
Royan Institute
1 site 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 MNC and CD133 in people with Liver Cirrhosis, run by Royan Institute 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 4 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: finished, as of the sponsor's last update on 28 Apr 2014. 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 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). 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 28 Apr 2014.