Liver CirrhosisPhase 1/2NCT01728727
Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis
A Phase 1/2 study testing UC-MSC transplantation and conventional 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?
- UC-MSC transplantation and conventional 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.the heart,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
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.
Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety and efficacy of hUC-MSC treatment for these patients.
- Conditions
- Liver Cirrhosis, End Stage Liver Disease
- Being tested
- UC-MSC transplantation, conventional treatment
- Keywords
- liver cirrhosis, end stage liver disease, umbilical cord, mesenchymal stem cells, HBV
- 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.
UC-MSC transplantationOther
After enrolled, Participant will receive umbilical cord MSC transplantation of 1*10E6 cells/kg via hepatic artery. Participant will then be followed until 1 years study visit
conventional treatmentOther
Participants will receive conventional treatment and antiviral treatment.
| Study group | Role | What they receive |
|---|---|---|
| conventional | Active comparator | conventional treatment \& antiviral treatment Receives: Other: conventional treatment |
| UC-MSC transplantation | Experimental | Participants will receive umbilical cord derived mesenchymal stem cell treatment at day 1 and conventional treatment and antiviral treatment through the one year study visit. Participants will then be followed until one years study visit Receives: Other: UC-MSC 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, 9months and 1year after treatment
Child Pugh Score
Measured: 1week, 4weeks,3months, 6months, 9months and 1year after treatment
alpha fetoprotein
Measured: 1week, 4weeks,3months, 6months, 9months and 1year after treatment
renal function
Measured: 1week, 4weeks,3months, 6months, 9months 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 posted20 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
- NCT01728727
- Sponsor's protocol ID
- 20120912-3
- Status last verified
- Nov 2012
- First submitted
- 31 Oct 2012
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT01728727
- Acronym / sponsor ID
- 20120912-3
- Conditions
- Liver Cirrhosis, End Stage Liver Disease
- Keywords
- liver cirrhosis, end stage liver disease, umbilical cord, mesenchymal stem cells, HBV
- 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
- 20 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.
Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety and efficacy of hUC-MSC 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 | Active comparator | Other: conventional treatmentconventional treatment \& antiviral treatment |
| UC-MSC transplantation | Experimental | Other: UC-MSC transplantationParticipants will receive umbilical cord derived mesenchymal stem cell treatment at day 1 and conventional treatment and antiviral treatment through the one year study visit. Participants will then be followed until one years study visit |
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.the heart,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 |
|---|---|---|
| UC-MSC transplantationAfter enrolled, Participant will receive umbilical cord MSC transplantation of 1*10E6 cells/kg via hepatic artery. Participant will then be followed until 1 years study visit | Other | UC-MSC transplantation |
| conventional treatmentParticipants will receive conventional treatment and antiviral treatment. | Other | conventional |
Primary outcome
one year survival rate
Time frame: one year after treatment
4 secondary outcomes
MELD score
Time frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment
Child Pugh Score
Time frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment
alpha fetoprotein
Time frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment
renal function
Time frame: 1week, 4weeks,3months, 6months, 9months 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 20 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 UC-MSC transplantation and conventional 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 20 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?
Contact ying han (86-29-84771539, hanying@fmmu.edu.cn), or a site near the patient. 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 20 Nov 2012.