Liver FailureNCT00956891
Therapeutic Effects of Liver Failure Patients Caused by Chronic Hepatitis B After Autologous MSCs Transplantation
An observational study of Liver Failure and Mesenchymal Stem Cells, run by Sun Yat-sen University at 1 site in China.
Trial summary
The study aimed to investigate the short-term efficacy and long-term prognosis of liver failure patients caused by hepatitis B after single transplantation with autologous marrow mesenchymal stem cells (MMSCs). Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Liver Failure, Mesenchymal Stem Cells
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- May 2005to Jul 2010
- Phase
- Observational
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Liver failure patients with HBV infection
Who may be able to join
- Liver failure
Who cannot join
- HBV negative
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital Of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: Therapeutic Effects Including Short-term Changes And Long-term Outcomes of Liver Failure Patients Caused by Chronic Hepatitis B After Single Transplantation With Autologous Bone Marrow Mesenchymal Stem Cells.
The study aimed to investigate the short-term efficacy and long-term prognosis of liver failure patients caused by hepatitis B after single transplantation with autologous marrow mesenchymal stem cells (MMSCs). Liver failure inpatients caused by hepatitis B were recruited and received the same medical treatments, among whom some patients underwent single transplantation with autologous MMSCs and other patients with matched age, gender and biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT) and Model for End-stage Liver Disease (MELD) ] were in control group. A total of 120 ml bone marrow were obtained from patients, diluted and separated. Then MMSCs suspension were slowly transfused into the liver through the proper hepatic artery by interventional procedures. The levels of ALB, TBIL, PT and MELD score of patients in translation group were compared with those in control group. In 3 ~ 48 months of follow-up, differences in long-term outcomes such as incidence of HCC (hepatocellular carcinoma) and mortality between two groups were compared.
Read the detailed description
A total of 527 patients with chronic hepatitis B induced liver failure were recruited from May 2005 to June 2009 from our department. The diagnoses of chronic hepatitis B and liver failure were based on previously described criteria. All patients received the same medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin). Informed consent was obtained before study. Among these patients, 53 received transplantation with autologous MMSCs. The day of surgery served as the first day of observation. And 105 patients with matched age, gender and some biochemical indexes (ALT, ALB, TBIL, PT and MELD ) were served as controls.
- Conditions
- Liver Failure, Mesenchymal Stem Cells
- Keywords
- short-term effects, long-term follow-up, liver failure patients, autologous MSCs transplantation
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group A | autologous MSCs transplantation were performed plus medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin) | |
| group B | only medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin) were performed without autologous MSCs transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term therapeutic effects of transplantation.
Biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT) and Model for End-stage Liver Disease (MELD) ] were compared 1 to 4 weeks after transplantation.
Measured: 1 to 4 weeks after transplantation
Secondary outcomes (1)
Long-term outcomes of transplantation.
In 3 ~ 48 months of follow-up, incidence of HCC (hepatocellular carcinoma) and mortality were compared between two groups.
Measured: 3 ~ 48 months years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startMay 2005
- Primary completionJun 2009
- Study completionJul 2010
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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Zhi-liang Gao, Dr, Study director, Department of Infectious Diseases, 3rd Affiliated Hospital of Sun Yat-sen University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956891
- Sponsor's protocol ID
- SunYat-senU 5010 hepatitisB
- Status last verified
- Aug 2009
- First submitted
- 10 Aug 2009
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects Including Short-term Changes And Long-term Outcomes of Liver Failure Patients Caused by Chronic Hepatitis B After Single Transplantation With Autologous Bone Marrow Mesenchymal Stem Cells.
- ClinicalTrials.gov ID
- NCT00956891
- Acronym / sponsor ID
- SunYat-senU 5010 hepatitisB
- Conditions
- Liver Failure, Mesenchymal Stem Cells
- Keywords
- short-term effects, long-term follow-up, liver failure patients, autologous MSCs transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 11 Aug 2009 (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.
The study aimed to investigate the short-term efficacy and long-term prognosis of liver failure patients caused by hepatitis B after single transplantation with autologous marrow mesenchymal stem cells (MMSCs). Liver failure inpatients caused by hepatitis B were recruited and received the same medical treatments, among whom some patients underwent single transplantation with autologous MMSCs and other patients with matched age, gender and biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT) and Model for End-stage Liver Disease (MELD) ] were in control group. A total of 120 ml bone marrow were obtained from patients, diluted and separated. Then MMSCs suspension were slowly transfused into the liver through the proper hepatic artery by interventional procedures. The levels of ALB, TBIL, PT and MELD score of patients in translation group were compared with those in control group. In 3 ~ 48 months of follow-up, differences in long-term outcomes such as incidence of HCC (hepatocellular carcinoma) and mortality between two groups were compared.
Detailed description
A total of 527 patients with chronic hepatitis B induced liver failure were recruited from May 2005 to June 2009 from our department. The diagnoses of chronic hepatitis B and liver failure were based on previously described criteria. All patients received the same medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin). Informed consent was obtained before study. Among these patients, 53 received transplantation with autologous MMSCs. The day of surgery served as the first day of observation. And 105 patients with matched age, gender and some biochemical indexes (ALT, ALB, TBIL, PT and MELD ) were served as controls.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | –autologous MSCs transplantation were performed plus medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin) |
| group B | – | –only medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin) were performed without autologous MSCs transplantation. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Liver failure patients with HBV infection
Key inclusion criteria (1 listed)
- Liver failure
Key exclusion criteria (1 listed)
- HBV negative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short-term therapeutic effects of transplantation.
Time frame: 1 to 4 weeks after transplantation
Biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT) and Model for End-stage Liver Disease (MELD) ] were compared 1 to 4 weeks after transplantation.
1 secondary outcome
Long-term outcomes of transplantation.
Time frame: 3 ~ 48 months years after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2010.
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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, Dr study director
Department of Infectious Diseases, 3rd Affiliated Hospital of Sun Yat-sen University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Failure and Mesenchymal Stem Cells, run by 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Dec 2010. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Short-term therapeutic effects of transplantation. (time frame: 1 to 4 weeks after transplantation). 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 7 Dec 2010.