Liver FailurePhase 1/2NCT01724398
Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Liver Failure
A Phase 1/2 study testing Conventional plus UC-MSC treatment, Conventional plus PE treatment and Conventional plus UC-MSC and PE therapy in people with Liver Failure, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. Although liver transplantation provides an option to cure patients suffering with LF, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Liver Failure
- What is being tested?
- Conventional plus UC-MSC treatment, Conventional plus PE treatment and Conventional plus UC-MSC and PE therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Mar 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent
- Acute-on-Chronic liver failure caused by hepatitis B virus
- Model for End-Stage Liver Disease (MELD) <30
Who cannot join
- Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
- History of severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment
- Severe problems in other vital organs(e.g. the heart, renal or lungs)
- Severe bacteria infection
- Tumor on ultrasonography, CT or MRI examination
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Zhi-Liang Gao, Professor, 86-20-85252373, zhilianggao@21cn.com
Hong-Liang He, Master, 86-20-85253372, hehongliang0925@sina.com
About this study
Official title: Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Acute-on-Chronic Liver Failure Caused by Hepatitis B Virus (HBV)
Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. Although liver transplantation provides an option to cure patients suffering with LF, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) the novel and promising therapeutic strategy, BM-MSCs can replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. Plasma exchange (PE) can improve internal environment by removing endotoxin, it helps the liver regeneration and functional recovery and make UC-MSC differentiation into hepatocyte like cells, and exert immunomodulatory function. In this study, safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B Virus will be evaluated.
Read the detailed description
To investigate safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B virus.
- Conditions
- Liver Failure
- Being tested
- Conventional plus UC-MSC treatment, Conventional plus PE treatment, Conventional plus UC-MSC and PE therapy, Conventional treatment
- Keywords
- mesenchymal stem cells, plasma exchange, liver failure, hepatitis B virus
- Medical subject headings
- Liver Failure, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional plus UC-MSC treatmentOther
Received conventional treatment and umbilical cord mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×105/Kg, once a week, 4 times).
Conventional plus PE treatmentOther
Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times).
Conventional plus UC-MSC and PE therapyOther
Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times). Meantime taken i.v umbilical cord mesenchymal stem cells transplantation slowly for 30minutes (1×105/Kg, once a week, 4 times), the first two times is taken after plasma exchange.
Conventional treatmentOther
Received conventional treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Experimental | Participants will receive conventional treatment and then be followed until the week 48 study visit. Receives: Other: Conventional treatment |
| Conventional plus UC-MSC treatment | Experimental | Participants will receive conventional treatment plus a dose of UC-MSC and then be followed until the week 48 study visit. Receives: Other: Conventional plus UC-MSC treatment |
| Conventional plus PE treatment | Experimental | Participants will receive conventional treatment plus plasma exchange and then be followed until the week 48 study visit. Receives: Other: Conventional plus PE treatment |
| Conventional plus UC-MSC and PE therapy | Experimental | Participants will receive conventional treatment plus umbilical cord mesenchymal stem cells transplantation combined with plasma exchange. Participants will then be followed until the week 48 study visit. Receives: Other: Conventional plus UC-MSC and PE therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate and time
Measured: 48 weeks
Secondary outcomes (6)
Improve biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT), INR and so on]
Measured: 24 weeks after treatment
The clinical symptom improvement [including appetite, debilitation, abdominal distension, edema of lower limbs, et al]
Measured: 24 weeks after treatment
Liver function evaluation using Child-Pugh score and MELD score
Measured: 24 weeks after treatment
Immune function improvement [including Th1/Th2]
Measured: 24 weeks after treatment
The occurrence of complications [including body temperature, tetter and allergy]
Measured: Between 0 to 8 hours after UC-MSCs transfusion
Incidence of hepatocellular carcinoma
Measured: 48 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 posted9 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Zhi-Liang Gao, Doctor, Principal investigator, The Third Affliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724398
- Sponsor's protocol ID
- UCMSC-PE
- Status last verified
- Feb 2013
- First submitted
- 4 Nov 2012
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xu WX, He HL, Pan SW, Chen YL, Zhang ML, Zhu S, Gao ZL, Peng L, Li JG. Combination Treatments of Plasma Exchange and Umbilical Cord-Derived Mesenchymal Stem Cell Transplantation for Patients with Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Clinical Trial in China. Stem Cells Int. 2019 Feb 4;2019:4130757. doi: 10.1155/2019/4130757. eCollection 2019.
PubMed 30863450
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Acute-on-Chronic Liver Failure Caused by Hepatitis B Virus (HBV)
- ClinicalTrials.gov ID
- NCT01724398
- Acronym / sponsor ID
- UCMSC-PE
- Conditions
- Liver Failure
- Keywords
- mesenchymal stem cells, plasma exchange, liver failure, hepatitis B virus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 9 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.
Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. Although liver transplantation provides an option to cure patients suffering with LF, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) the novel and promising therapeutic strategy, BM-MSCs can replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. Plasma exchange (PE) can improve internal environment by removing endotoxin, it helps the liver regeneration and functional recovery and make UC-MSC differentiation into hepatocyte like cells, and exert immunomodulatory function. In this study, safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B Virus will be evaluated.
Detailed description
To investigate safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Experimental | Other: Conventional treatmentParticipants will receive conventional treatment and then be followed until the week 48 study visit. |
| Conventional plus UC-MSC treatment | Experimental | Other: Conventional plus UC-MSC treatmentParticipants will receive conventional treatment plus a dose of UC-MSC and then be followed until the week 48 study visit. |
| Conventional plus PE treatment | Experimental | Other: Conventional plus PE treatmentParticipants will receive conventional treatment plus plasma exchange and then be followed until the week 48 study visit. |
| Conventional plus UC-MSC and PE therapy | Experimental | Other: Conventional plus UC-MSC and PE therapyParticipants will receive conventional treatment plus umbilical cord mesenchymal stem cells transplantation combined with plasma exchange. Participants will then be followed until the week 48 study visit. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Acute-on-Chronic liver failure caused by hepatitis B virus
- Model for End-Stage Liver Disease (MELD) <30
Key exclusion criteria (6 listed)
- Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
- History of severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment
- Severe problems in other vital organs(e.g. the heart, renal or lungs)
- Severe bacteria infection
- Tumor on ultrasonography, CT or MRI examination
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 UC-MSC treatmentReceived conventional treatment and umbilical cord mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×105/Kg, once a week, 4 times). | Other | Conventional plus UC-MSC treatment |
| Conventional plus PE treatmentReceived conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times). | Other | Conventional plus PE treatment |
| Conventional plus UC-MSC and PE therapyReceived conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times). Meantime taken i.v umbilical cord mesenchymal stem cells transplantation slowly for 30minutes (1×105/Kg, once a week, 4 times), the first two times is taken after plasma exchange. | Other | Conventional plus UC-MSC and PE therapy |
| Conventional treatmentReceived conventional treatment including antiviral drugs, lowering aminotransferase and jaundice medicine. | Other | Conventional treatment |
Primary outcome
Survival rate and time
Time frame: 48 weeks
6 secondary outcomes
Improve biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT), INR and so on]
Time frame: 24 weeks after treatment
The clinical symptom improvement [including appetite, debilitation, abdominal distension, edema of lower limbs, et al]
Time frame: 24 weeks after treatment
Liver function evaluation using Child-Pugh score and MELD score
Time frame: 24 weeks after treatment
Immune function improvement [including Th1/Th2]
Time frame: 24 weeks after treatment
The occurrence of complications [including body temperature, tetter and allergy]
Time frame: Between 0 to 8 hours after UC-MSCs transfusion
Incidence of hepatocellular carcinoma
Time frame: 48 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 28 Feb 2013.
- Derived from this study: PubMed 30863450Xu WX, He HL, Pan SW, Chen YL, Zhang ML, Zhu S, Gao ZL, Peng L, Li JG. Combination Treatments of Plasma Exchange and Umbilical Cord-Derived Mesenchymal Stem Cell Transplantation for Patients with Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Clinical Trial in China. Stem Cells Int. 2019 Feb 4;2019:4130757. doi: 10.1155/2019/4130757. eCollection 2019.
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LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
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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.
Zhi-Liang Gao, Doctor principal investigator
The Third Affliated Hospital of 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 UC-MSC treatment, Conventional plus PE treatment and Conventional plus UC-MSC and PE therapy 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 3 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 28 Feb 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 Zhi-Liang Gao, Professor (86-20-85252373, zhilianggao@21cn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate and time (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01724398, which also lists 1 linked publication.
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 28 Feb 2013.