Liver CirrhosisPhase 1/2NCT00382278
Safety Study of Autologous Stem Cell in Liver Cirrhosis
A Phase 1/2 study testing Autologous bone marrow-derived mononuclear cells infusion in people with Liver Cirrhosis, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
It is a fase I/II clinical study to evaluate feasibility, safety and kinetics of cellular therapy with bone marrow-derived mononuclear cells (ABMMC) in patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Autologous bone marrow-derived mononuclear cells infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2005to Feb 2008
- 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 cirrhosis of any origin
- Moderate liver disfunction (Child-Pugh Score=7-10)
Who cannot join
- Waiting time expectancy of liver transplant shorter than 12 months
- Ongoing hepatic encephalopathy
- Clinically detectable ascitis
- Severe coagulation disorder (INR>2,0 or platelets count < 40.000)
- Diagnosis or strong suspicion of cancer (except basocellular)
- Pregnancy or intention to become pregnant during the next 12 months
- Moderate or severe co-morbidity
- Current participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Rio de Janeiro, 21941-590
About this study
Official title: Phase 1/2 Study of Autologous Bone Marrow Derived Mononuclear Cells in Liver Cirrhosis
It is a fase I/II clinical study to evaluate feasibility, safety and kinetics of cellular therapy with bone marrow-derived mononuclear cells (ABMMC) in patients with liver cirrhosis. All the patients have moderate liver disfunction and a waiting time expectancy of liver transplantation longer than 12 months due their low MELD score. The ABMMC are labeled with 99mTc and infused through the hepatic artery. Scintigraphy is performed 2 and 24 hours after infusion. Patients are submitted to frequent clinical, laboratorial and image evaluation during the follow up period of 12 months.
Read the detailed description
A one year clinical trial was conducted. Patients had moderate liver dysfunction and a liver transplant was not expected to occur earlier than 12 months, due to low MELD scores. Hepatocellular carcinoma (HCC) and hepatic artery or portal vein thrombosis were excluded by color Doppler ultrasonography (DUS) and 3-phase computed tomography (CT). Under local anesthesia, 100 mL of bone marrow were aspirated from the posterior iliac crest. ABMMC were isolated by density gradient centrifugation in Ficoll-Hypaque gradient, 10% of the cells were labeled with SnCl2-99mTc, and a small fraction was used for cell counting and viability analysis. ABMMC were delivered preferentially in the common hepatic artery by celiac trunk catheterism. Total body scintigraphy (TBS) was performed 3 hours after infusion. Patients were submitted to frequent clinical, biochemical and imaging evaluation during follow up.
- Conditions
- Liver Cirrhosis
- Being tested
- Autologous bone marrow-derived mononuclear cells infusion
- Keywords
- Stem cell, Liver cirrhosis, Cellular therapy, Autologous, Bone marrow
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow-derived mononuclear cells infusionProcedure or surgery
Under local anesthesia, 100 mL of bone marrow were aspirated from the posterior iliac crest. ABMMC were isolated by density gradient centrifugation in Ficoll-Hypaque gradient, 10% of the cells were labeled with SnCl2-99mTc, and a small fraction was used for cell counting and viability analysis. At least 100 millions of mononuclear-enriched BMC suspended in 20 mL of saline were delivered preferentially in the common hepatic artery by celiac trunk catheterism.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in liver function according to Child-Pugh and MELD scores
Measured: in days 1,2,7,14,30, 45, 60, 90, 120, 150, 180, 270, 360
Hepatic artery and portal vein thrombosis (doppler ultrasound)
Measured: in days 1,2,7,14,90, 180 and 360
Development of liver nodule (ultrasound screening)
Measured: in days 1,2,7,14,90, 180 and 360 (US) and in day 360 (CT scan )
Liver related mortality
Measured: 360 days
Secondary outcomes (1)
Body distribution of 99mTc labeled BMDMC (scintigraphy)
Measured: after 3 hours of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startNov 2005
- Primary completionDec 2007
- Study completionFeb 2008
Why it stopped: Other authors showed the same metabolic effect may be obtained when BMMC are delivered peripherally, with lower risk and cost than through hepatic artery.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Investigators
- Guilherme FM Rezende, MD, PhD, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382278
- Sponsor's protocol ID
- CELTHEP-01
- Status last verified
- Feb 2008
- First submitted
- 28 Sep 2006
- Last updated
- 3 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of Autologous Bone Marrow Derived Mononuclear Cells in Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT00382278
- Acronym / sponsor ID
- CELTHEP-01
- Conditions
- Liver Cirrhosis
- Keywords
- Stem cell, Liver cirrhosis, Cellular therapy, Autologous, Bone marrow
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Other authors showed the same metabolic effect may be obtained when BMMC are delivered peripherally, with lower risk and cost than through hepatic artery.
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Study start
- Nov 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 29 Sep 2006 (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.
It is a fase I/II clinical study to evaluate feasibility, safety and kinetics of cellular therapy with bone marrow-derived mononuclear cells (ABMMC) in patients with liver cirrhosis. All the patients have moderate liver disfunction and a waiting time expectancy of liver transplantation longer than 12 months due their low MELD score. The ABMMC are labeled with 99mTc and infused through the hepatic artery. Scintigraphy is performed 2 and 24 hours after infusion. Patients are submitted to frequent clinical, laboratorial and image evaluation during the follow up period of 12 months.
Detailed description
A one year clinical trial was conducted. Patients had moderate liver dysfunction and a liver transplant was not expected to occur earlier than 12 months, due to low MELD scores. Hepatocellular carcinoma (HCC) and hepatic artery or portal vein thrombosis were excluded by color Doppler ultrasonography (DUS) and 3-phase computed tomography (CT). Under local anesthesia, 100 mL of bone marrow were aspirated from the posterior iliac crest. ABMMC were isolated by density gradient centrifugation in Ficoll-Hypaque gradient, 10% of the cells were labeled with SnCl2-99mTc, and a small fraction was used for cell counting and viability analysis. ABMMC were delivered preferentially in the common hepatic artery by celiac trunk catheterism. Total body scintigraphy (TBS) was performed 3 hours after infusion. Patients were submitted to frequent clinical, biochemical and imaging evaluation during follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Liver cirrhosis of any origin
- Moderate liver disfunction (Child-Pugh Score=7-10)
Key exclusion criteria (8 listed)
- Waiting time expectancy of liver transplant shorter than 12 months
- Ongoing hepatic encephalopathy
- Clinically detectable ascitis
- Severe coagulation disorder (INR>2,0 or platelets count < 40.000)
- Diagnosis or strong suspicion of cancer (except basocellular)
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 bone marrow-derived mononuclear cells infusionUnder local anesthesia, 100 mL of bone marrow were aspirated from the posterior iliac crest. ABMMC were isolated by density gradient centrifugation in Ficoll-Hypaque gradient, 10% of the cells were labeled with SnCl2-99mTc, and a small fraction was used for cell counting and viability analysis. At least 100 millions of mononuclear-enriched BMC suspended in 20 mL of saline were delivered preferentially in the common hepatic artery by celiac trunk catheterism. | Procedure or surgery | – |
Primary outcome
Changes in liver function according to Child-Pugh and MELD scores
Time frame: in days 1,2,7,14,30, 45, 60, 90, 120, 150, 180, 270, 360
Hepatic artery and portal vein thrombosis (doppler ultrasound)
Time frame: in days 1,2,7,14,90, 180 and 360
Development of liver nodule (ultrasound screening)
Time frame: in days 1,2,7,14,90, 180 and 360 (US) and in day 360 (CT scan )
Liver related mortality
Time frame: 360 days
1 secondary outcome
Body distribution of 99mTc labeled BMDMC (scintigraphy)
Time frame: after 3 hours of infusion
Results and safety
The study was stopped early (reason given: Other authors showed the same metabolic effect may be obtained when BMMC are delivered peripherally, with lower risk and cost than through hepatic artery.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2008.
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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.
Guilherme FM Rezende, MD, PhD principal investigator
Universidade Federal do Rio de Janeiro
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 Autologous bone marrow-derived mononuclear cells infusion in people with Liver Cirrhosis, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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 8 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: stopped early, as of the sponsor's last update on 3 Apr 2008. 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 Brazil. 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 was stopped early (reason given: Other authors showed the same metabolic effect may be obtained when BMMC are delivered peripherally, with lower risk and cost than through hepatic artery.). 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?
Changes in liver function according to Child-Pugh and MELD scores (time frame: in days 1,2,7,14,30, 45, 60, 90, 120, 150, 180, 270, 360). The study lists 4 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 3 Apr 2008.