Liver CirrhosisPhase 1/2NCT01724697
Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis
A Phase 1/2 study testing BMSC transplantation and conventional treatment & antivrial treatment in people with Liver Cirrhosis and End Stage Liver Disease, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related hepatitis can developed into liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Cirrhosis, End Stage Liver Disease
- What is being tested?
- BMSC transplantation and conventional treatment & antivrial treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Sep 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- HBV-related liver cirrhosis
- Child-Pugh score 9-15
- Written consent
Who cannot join
- Hepatocellular carcinoma or other malignancies
- Severe problems in other vital organs(e.g.theheart,renal or lungs)
- Pregnant or lactating women
- Severe bacteria infection
- Anticipated with difficulty of follow-up observation
- Other candidates who are judged to be not applicable to this study by doctors
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Digestive Disease
Xi'an, Shaanxi, 710032
Ying Han, 86-29-84771539, hanying@fmmu.edu.cn
Yongquan Shi, 86-29-84771515, shiyquan@fmmu.edu.cn
About this study
Official title: Safety and Efficacy of Human Autologous Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis
HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related hepatitis can developed into liver cirrhosis.
Liver transplantation is the only available life saving treatment for patients with end stage liver disease. However, lack of donors, surgical complications, rejection, and high cost are serious problems.
stem cells(SCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, SCs hold great hope for therapeutic applications. Adult bone marrow is the most common source of SCs for clinical applications.Previous study showed that bone marrow derived stem cells (BMSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. In this study, the patients with HBV-related liver cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to evaluate the safty and efficacy of human autologous BMSCs treatment for these patients.
- Conditions
- Liver Cirrhosis, End Stage Liver Disease
- Being tested
- BMSC transplantation, conventional treatment & antivrial treatment
- Keywords
- liver cirrhosis, end stage liver disease, HBV, autologous, stem cell, bone morrow
- Medical subject headings
- Liver Cirrhosis, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMSC transplantationOther
Patients randomized to the intervention arm will be collected for bone marrow stem cells and then infused with these cells via hepatic artery.
conventional treatment & antivrial treatmentOther
Participants will recieve conventional treatment and antivrial treatment.
| Study group | Role | What they receive |
|---|---|---|
| conventional treatment | Active comparator | conventional treatment \& antivrial treatment. Receives: Other: conventional treatment & antivrial treatment |
| BMSC transplantation | Experimental | conventional treatment \& antiviral treatment \& autologous bone marrow stem cell transplantation via hepatic artery Receives: Other: BMSC transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
one year survival rate
Measured: one year after treatment
Secondary outcomes (4)
MELD score
Measured: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
AFP
Measured: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
renal function
Measured: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
child score
Measured: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2015 (estimated)
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
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, Eastern Hepatobiliary Surgery Hospital, Chinese Academy of Medical Sciences, Fudan University
- Responsible party
- Principal investigator, Han Ying, Air Force Military Medical University, China
- Investigators
- Daiming Fan, Study chair, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724697
- Sponsor's protocol ID
- 20120912-1
- Status last verified
- Nov 2012
- First submitted
- 31 Oct 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Human Autologous Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT01724697
- Acronym / sponsor ID
- 20120912-1
- Conditions
- Liver Cirrhosis, End Stage Liver Disease
- Keywords
- liver cirrhosis, end stage liver disease, HBV, autologous, stem cell, bone morrow
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, Eastern Hepatobiliary Surgery Hospital, Chinese Academy of Medical Sciences, Fudan University
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 12 Nov 2012 (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.
HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related hepatitis can developed into liver cirrhosis.
Liver transplantation is the only available life saving treatment for patients with end stage liver disease. However, lack of donors, surgical complications, rejection, and high cost are serious problems.
stem cells(SCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, SCs hold great hope for therapeutic applications. Adult bone marrow is the most common source of SCs for clinical applications.Previous study showed that bone marrow derived stem cells (BMSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. In this study, the patients with HBV-related liver cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to evaluate the safty and efficacy of human autologous BMSCs treatment for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional treatment | Active comparator | Other: conventional treatment & antivrial treatmentconventional treatment \& antivrial treatment. |
| BMSC transplantation | Experimental | Other: BMSC transplantationconventional treatment \& antiviral treatment \& autologous bone marrow stem cell transplantation via hepatic artery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65 years
- HBV-related liver cirrhosis
- Child-Pugh score 9-15
- Written consent
Key exclusion criteria (6 listed)
- Hepatocellular carcinoma or other malignancies
- Severe problems in other vital organs(e.g.theheart,renal or lungs)
- Pregnant or lactating women
- Severe bacteria infection
- Anticipated with difficulty of follow-up observation
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 |
|---|---|---|
| BMSC transplantationPatients randomized to the intervention arm will be collected for bone marrow stem cells and then infused with these cells via hepatic artery. | Other | BMSC transplantation |
| conventional treatment & antivrial treatmentParticipants will recieve conventional treatment and antivrial treatment. | Other | conventional treatment |
Primary outcome
one year survival rate
Time frame: one year after treatment
4 secondary outcomes
MELD score
Time frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
AFP
Time frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
renal function
Time frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
child score
Time frame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
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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.
Daiming Fan study chair
Air Force Military Medical University, China
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 BMSC transplantation and conventional treatment & antivrial treatment in people with Liver Cirrhosis and End Stage Liver Disease, run by Air Force Military Medical University, China at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 12 Nov 2012. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one year survival rate (time frame: one year after treatment). 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 12 Nov 2012.