Liver FailurePhase 2NCT02812121
UC-MSC Infusion for HBV-Related Acute-on-Chronic Liver Failure
A Phase 2 study testing umbilical cord blood mesenchymal stem cells in people with Liver Failure, run by Sun Yat-sen University.
Trial summary
Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. Our previous study have demonstrated that peripheral infusion of bone marrow-derived mesenchymal stromal cells (MSCs) weekly for 4 times is safe and improves 24 weeks survival rate of ACLF patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Failure
- What is being tested?
- umbilical cord blood mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2018
- Phase
- Phase 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
- Patients with ACLF-which is characterized by acute hepatic insult manifesting as jaundice (serum total bilirubin ≥ 10×ULN umol/L) and coagulopathy (international normalized ratio≥ 1.5 or prothrombin activity < 40%), complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination, in patients with previously diagnosed or undiagnosed chronic liver disease;
- Positive serum hepatitis B surface antigen (HBsAg) for more than 6 months;
- End-stage liver disease scores ranging from 17-30,; 4.18-65 years of age.
Who cannot join
- Serious complications within the previous 2 months (e.g. gastrointestinal bleeding, serious infection );
- Concomitant autoimmune disease;
- Superinfection with other hepatitis viruses;
- Important organ dysfunctions not due to liver disease or malignancies;
- Pregnancy and lactation;
- Liver tumor or nodules secondary to cirrhosis proven by ultrasound, computerized tomography (CT), or magnetic resonance (MR) imaging;
- Bioartificial liver support therapy;
- Previous liver transplantation.
About this study
Official title: Umbilical Cord Blood Derived Mesenchymal Stem Cells Infusion for HBV-Related Acute-on-Chronic Liver Failure: A Randomized Controlled Trial
Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. Our previous study have demonstrated that peripheral infusion of bone marrow-derived mesenchymal stromal cells (MSCs) weekly for 4 times is safe and improves 24 weeks survival rate of ACLF patients. In this study, we intend to assess the safety and efficacy of umbilical cord blood derived MSCs for HBV-related ACLF patients.
- Conditions
- Liver Failure
- Being tested
- umbilical cord blood mesenchymal stem cells
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord blood mesenchymal stem cellsDrug
| Study group | Role | What they receive |
|---|---|---|
| Group MSC-1 | Experimental | Patients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 8 weeks. Receives: Drug: umbilical cord blood mesenchymal stem cells |
| Group MSC-2 | Experimental | Patients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 4 weeks. Receives: Drug: umbilical cord blood mesenchymal stem cells |
| Group Control | No intervention | Patients in Group Control received standard medical treatment, including bed rest, nutritional supplementation, administration of human serum albumin (10g per day until serum albumin was 35g/L) and plasma (200 ml to 400 ml per day until the international normalized ratio was less than 1.5), anti-viral therapy, glycyrrhizin,S-adenosylmethionine and appropriate treatment for complications (such as infection, encephalopathy, hepatorenal syndrome and intestinal paralysis). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse reactions after umbilical cord blood derived mesenchymal stem cells (UC-MSC) infusions.
Measured: 52 weeks
The survival time of patients after UC-MSC infusions.
Measured: 52 weeks
Secondary outcomes (15)
The influence on levels of ALT (U/L) and AST (U/L) after UC-MSC infusions
Measured: 1,2,3,4,8,12,24,36,52weeks
The influence on levels of ALB(g/L) after UC-MSC infusions
Measured: 1,2,3,4,8,12,24,36,52weeks
The influence on levels of TBil (umol/L) after UC-MSC infusions
Measured: 1,2,3,4,8,12,24,36,52weeks
The influence on levels of INR after UC-MSC infusions
Measured: 1,2,3,4,8,12,24,36,52weeks
The influence on levels of MELD score, SOFA score and CTP score after UC-MSC infusions
Measured: 1,2,3,4,8,12,24,36,52weeks
The incidence of fatal complications after UC-MSC infusions.
Measured: 52 weeks
Comparison of levels of NKG2A among the groups after UC-MSC infusions
Measured: 2,4,8,12,24,36,52 weeks
Comparison of levels of NKG2D among the groups after UC-MSC infusions
Measured: 2,4,8,12,24,36,52 weeks
Comparison of levels of NKP46 among the groups after UC-MSC infusions
Measured: 2,4,8,12,24,36,52 weeks
Comparison of levels of KIR2DL1 among the groups after UC-MSC infusions
Measured: 2,4,8,12,24,36,52 weeks
Comparison of levels of KIR2DL3 among the groups after UC-MSC infusions
Measured: 2,4,8,12,24,36,52 weeks
Comparison of levels of KIR3DL1 among the groups after UC-MSC infusions
Measured: 2,4,8,12,24,36,52 weeks
Comparison of levels of perforin among the groups after UC-MSC infusions
Measured: 2,4,8,12,24,36,52 weeks
Comparison of levels of FasL among the groups after UC-MSC infusions
Measured: 2,4,8,12,24,36,52 weeks
Comparison of levels of gramzymeB among the groups after UC-MSC infusions
Measured: 2,4,8,12,24,36,52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Bingliang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812121
- Sponsor's protocol ID
- UCBMSC
- Other IDs
- LBingliang
- Status last verified
- Jun 2016
- First submitted
- 27 May 2016
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Blood Derived Mesenchymal Stem Cells Infusion for HBV-Related Acute-on-Chronic Liver Failure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02812121
- Acronym / sponsor ID
- UCBMSC
- Conditions
- Liver Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 261 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 24 Jun 2016 (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.
Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. Our previous study have demonstrated that peripheral infusion of bone marrow-derived mesenchymal stromal cells (MSCs) weekly for 4 times is safe and improves 24 weeks survival rate of ACLF patients. In this study, we intend to assess the safety and efficacy of umbilical cord blood derived MSCs for HBV-related ACLF patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group MSC-1 | Experimental | Drug: umbilical cord blood mesenchymal stem cellsPatients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 8 weeks. |
| Group MSC-2 | Experimental | Drug: umbilical cord blood mesenchymal stem cellsPatients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 4 weeks. |
| Group Control | No intervention | –Patients in Group Control received standard medical treatment, including bed rest, nutritional supplementation, administration of human serum albumin (10g per day until serum albumin was 35g/L) and plasma (200 ml to 400 ml per day until the international normalized ratio was less than 1.5), anti-viral therapy, glycyrrhizin,S-adenosylmethionine and appropriate treatment for complications (such as infection, encephalopathy, hepatorenal syndrome and intestinal paralysis). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with ACLF-which is characterized by acute hepatic insult manifesting as jaundice (serum total bilirubin ≥ 10×ULN umol/L) and coagulopathy (international normalized ratio≥ 1.5 or prothrombin activity < 40%), complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination, in patients with previously diagnosed or undiagnosed chronic liver disease;
- Positive serum hepatitis B surface antigen (HBsAg) for more than 6 months;
- End-stage liver disease scores ranging from 17-30,; 4.18-65 years of age.
Key exclusion criteria (8 listed)
- Serious complications within the previous 2 months (e.g. gastrointestinal bleeding, serious infection );
- Concomitant autoimmune disease;
- Superinfection with other hepatitis viruses;
- Important organ dysfunctions not due to liver disease or malignancies;
- Pregnancy and lactation;
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 |
|---|---|---|
| umbilical cord blood mesenchymal stem cells | Drug | Group MSC-1, Group MSC-2 |
Primary outcome
The incidence of adverse reactions after umbilical cord blood derived mesenchymal stem cells (UC-MSC) infusions.
Time frame: 52 weeks
The survival time of patients after UC-MSC infusions.
Time frame: 52 weeks
15 secondary outcomes
The influence on levels of ALT (U/L) and AST (U/L) after UC-MSC infusions
Time frame: 1,2,3,4,8,12,24,36,52weeks
The influence on levels of ALB(g/L) after UC-MSC infusions
Time frame: 1,2,3,4,8,12,24,36,52weeks
The influence on levels of TBil (umol/L) after UC-MSC infusions
Time frame: 1,2,3,4,8,12,24,36,52weeks
The influence on levels of INR after UC-MSC infusions
Time frame: 1,2,3,4,8,12,24,36,52weeks
The influence on levels of MELD score, SOFA score and CTP score after UC-MSC infusions
Time frame: 1,2,3,4,8,12,24,36,52weeks
The incidence of fatal complications after UC-MSC infusions.
Time frame: 52 weeks
Comparison of levels of NKG2A among the groups after UC-MSC infusions
Time frame: 2,4,8,12,24,36,52 weeks
Comparison of levels of NKG2D among the groups after UC-MSC infusions
Time frame: 2,4,8,12,24,36,52 weeks
Comparison of levels of NKP46 among the groups after UC-MSC infusions
Time frame: 2,4,8,12,24,36,52 weeks
Comparison of levels of KIR2DL1 among the groups after UC-MSC infusions
Time frame: 2,4,8,12,24,36,52 weeks
Comparison of levels of KIR2DL3 among the groups after UC-MSC infusions
Time frame: 2,4,8,12,24,36,52 weeks
Comparison of levels of KIR3DL1 among the groups after UC-MSC infusions
Time frame: 2,4,8,12,24,36,52 weeks
Comparison of levels of perforin among the groups after UC-MSC infusions
Time frame: 2,4,8,12,24,36,52 weeks
Comparison of levels of FasL among the groups after UC-MSC infusions
Time frame: 2,4,8,12,24,36,52 weeks
Comparison of levels of gramzymeB among the groups after UC-MSC infusions
Time frame: 2,4,8,12,24,36,52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing umbilical cord blood mesenchymal stem cells in people with Liver Failure, run by Sun Yat-sen University.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
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?
The incidence of adverse reactions after umbilical cord blood derived mesenchymal stem cells (UC-MSC) infusions. (time frame: 52 weeks). 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?
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 24 Jun 2016.