Liver FailurePhase 1/2NCT01844063
Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure
A Phase 1/2 study testing Conventional plus BM-MSC treatment, Conventional plus UC-MSC treatment and Conventional treatment in people with Liver Failure, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with massive necrosis of liver cells. Liver transplantation might be the most effective therapy for HBV-LF. 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?
- Conventional plus BM-MSC treatment, Conventional plus UC-MSC treatment and Conventional treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Jan 2019
- 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
- Liver failure
- Negative pregnancy test (female patients in fertile age)
- Written consent
- HBsAg positive
- TB≥171 μmol/L or ascend ≥17.1 μmol/L/per day,
- INR≥1.5 or 20%<PTA≤40%
- 17≤MELD score≤30
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
- Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
- 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
Qi Zhang
Guangzhou, Guangdong, 510630
Qi Zhang, Doctor
About this study
Official title: Clinical Comparison of Safety and Efficacy of Allogeneic Umbilical-Cord and Bone Marrow-derived Mesenchymal Stem Cells Transplantation for HBV-related Liver Failure
HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with massive necrosis of liver cells. Liver transplantation might be the most effective therapy for HBV-LF. However, there are a lot of problems such as lack of donors, surgical complications, transplant rejection, and high cost, which could limit the application of liver transplantation. It is demonstrated that mesenchymal stem cells could directionally differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce inflammation of the liver by immune regulation. In this study, we assess the safety and efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for patients with HBV-LF.
- Conditions
- Liver Failure
- Being tested
- Conventional plus BM-MSC treatment, Conventional plus UC-MSC treatment, Conventional treatment
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional plus BM-MSC treatmentGenetic
Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times).
Conventional plus UC-MSC treatmentGenetic
Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times)
Conventional treatmentDrug
Also called Antiviral drugs, Hepatoprotective drugs, Plasma
Received conventional treatment including:
A.antiviral drugs(Entecavir,Lamivudine,Adefovir dipivoxil,et al); B.Hepatoprotective drugs(Ademetionine1,4-butanethiosulfonate for Injection, Reduced Glutathione for Injection,Polyene Phosphatidylcholine, et al); C.Plasma.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Experimental | Participants will receive conventional treatment and then be followed until the week 72 study visit. Receives: Drug: Conventional treatment |
| Conventional plus BM-MSC treatment | Experimental | Participants will receive conventional treatment plus a dose of BM-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit. Receives: Genetic: Conventional plus BM-MSC treatment |
| Conventional plus UC-MSC treatment | Experimental | Participants will receive conventional treatment plus a dose of UC-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit. Receives: Genetic: Conventional plus UC-MSC treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
The survival rate and time
Measured: 72 weeks
Secondary outcomes (8)
Liver function
The levels of serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST),Cholinesterase (CHE) ,Total Bilirubin(TB),Direct Bilirubin(DB), Serum Albumin （ALB）
Measured: 72 weeks after treatment
Marker of liver cancer
The level of alpha-fetoprotein (AFP)
Measured: 72 weeks after treatment
The degree of hepatic necrosis
The levels of Prothrombin Activity (PA) and Prothrombin Time (PT)
Measured: 2 years after treatment
The improvement of symptoms
The improvement of clinical symptoms [including appetite, debilitation, abdominal distension, edema of lower limbs, et al
Measured: 72 weeks after treatment
The score for Model for End-Stage Liver Disease
Measured: 72 weeks after treatment
The improvement of immune function
cluster of differentiation 4 (CD4+)T/ cluster of differentiation 8 (CD8+)T,T helper cell 1 (Th1)/ T helper cell 1(Th2),natural killer cell(NK),natural killer T(NK T),interleukin-1β(IL-1β),interleukin-4(IL-4),interleukin-6(IL-6),interleukin-8(IL-8),interleukin-12(IL-12),interleukin-15(IL-15),interleukin-17A(IL-17A),Tumor necrosis factor-alpha (TNF-α),Interferon-gamma (IFN-γ)
Measured: 72 weeks after treatment
complications
The occurrence of complications [including body temperature, tetter and allergy]
Measured: Between 0 to 8 hours after MSC transfusion
The incidence of hepatocellular carcinoma
Measured: 72 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2016 (estimated)
- Study completionJan 2019 (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.
- 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
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Zhang, MD, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Qi Zhang, Doctor, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844063
- Sponsor's protocol ID
- The Third Affiliated Hospital
- Status last verified
- Jul 2013
- First submitted
- 20 Apr 2013
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Safety and Efficacy of Allogeneic Umbilical-Cord and Bone Marrow-derived Mesenchymal Stem Cells Transplantation for HBV-related Liver Failure
- ClinicalTrials.gov ID
- NCT01844063
- Acronym / sponsor ID
- The Third Affiliated Hospital
- Conditions
- Liver Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 1 May 2013 (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 failure (HBV-LF), a dramatic clinical syndrome, is characterized with massive necrosis of liver cells. Liver transplantation might be the most effective therapy for HBV-LF. However, there are a lot of problems such as lack of donors, surgical complications, transplant rejection, and high cost, which could limit the application of liver transplantation. It is demonstrated that mesenchymal stem cells could directionally differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce inflammation of the liver by immune regulation. In this study, we assess the safety and efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for patients with HBV-LF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Experimental | Drug: Conventional treatmentParticipants will receive conventional treatment and then be followed until the week 72 study visit. |
| Conventional plus BM-MSC treatment | Experimental | Genetic: Conventional plus BM-MSC treatmentParticipants will receive conventional treatment plus a dose of BM-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit. |
| Conventional plus UC-MSC treatment | Experimental | Genetic: Conventional plus UC-MSC treatmentParticipants will receive conventional treatment plus a dose of UC-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18-65 years
- Liver failure
- Negative pregnancy test (female patients in fertile age)
- Written consent
- HBsAg positive
Key exclusion criteria (7 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 |
|---|---|---|
| Conventional plus BM-MSC treatmentReceived conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times). | Genetic | Conventional plus BM-MSC treatment |
| Conventional plus UC-MSC treatmentReceived conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times) | Genetic | Conventional plus UC-MSC treatment |
| Conventional treatmentAlso: Antiviral drugs, Hepatoprotective drugs, PlasmaReceived conventional treatment including: A.antiviral drugs(Entecavir,Lamivudine,Adefovir dipivoxil,et al); B.Hepatoprotective drugs(Ademetionine1,4-butanethiosulfonate for Injection, Reduced Glutathione for Injection,Polyene Phosphatidylcholine, et al); C.Plasma. | Drug | Conventional treatment |
Primary outcome
survival rate
Time frame: 72 weeks
The survival rate and time
8 secondary outcomes
Liver function
Time frame: 72 weeks after treatment
Marker of liver cancer
Time frame: 72 weeks after treatment
The degree of hepatic necrosis
Time frame: 2 years after treatment
The improvement of symptoms
Time frame: 72 weeks after treatment
The score for Model for End-Stage Liver Disease
Time frame: 72 weeks after treatment
The improvement of immune function
Time frame: 72 weeks after treatment
complications
Time frame: Between 0 to 8 hours after MSC transfusion
The incidence of hepatocellular carcinoma
Time frame: 72 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
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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.
Qi Zhang, Doctor principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
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 Conventional plus BM-MSC treatment, Conventional plus UC-MSC treatment and Conventional treatment in people with Liver Failure, run by Third Affiliated Hospital, Sun Yat-Sen University 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 8 inclusion and 7 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 8 Jul 2013. 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 Qihuan Xu, Doctor (+86 20 85253179, xqh0303@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: 72 weeks). 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 8 Jul 2013.