Liver CirrhosisPhase 1/2NCT01342250
Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis
A Phase 1/2 study testing conventional therapy plus low dose hUC-MSCs treatment, conventional therapy plus medium dose hUC-MSCs treatment and conventional therapy plus high dose hUC-MSCs treatment in people with Liver Cirrhosis, run by Shenzhen Beike Bio-Technology Co., Ltd. at 1 site in China.
Trial summary
Although liver transplantation provide a option to cure patients suffering with decompensated liver cirrhosis this condition, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- conventional therapy plus low dose hUC-MSCs treatment, conventional therapy plus medium dose hUC-MSCs treatment and conventional therapy plus high dose hUC-MSCs treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Oct 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Aged 18-70 years.
- Decompensated liver cirrhosis, Child-Pugh B/C (7-12 points); or Meld score≦21.
- Expecting lifetime is over 2 months.
- Hepatitis B decompensated liver cirrhosis patients need antiviral therapy.
Who cannot join
- Severe drug allergic history or anaphylaxis.
- Severe problems in other vital organs(e.g. the heart, renal or lungs)
- Severe problems in psychiatric disease,such as Schizophrenia,et al
- Severe bacteria infection.
- Malignancies.
- Alcoholism or drug abuse.
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- Plan to have liver transplantation in 3 months.
- Pregnancy
- Candidates who are participating in other study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Liver Disease Research Center, the Nanjing Military Command (Shanghai 85 Hospital)
Shanghai, Shanghai Municipality, 200235
About this study
Official title: Phase Ι/Π Study of Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis
Although liver transplantation provide a option to cure patients suffering with decompensated liver cirrhosis this condition, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Bone marrow derived mesenchymal stem cells (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively rescued experimental liver failure and contributed to liver regeneration, which suggest the novel and promising therapeutic strategy In this study, the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSCs) transplantation for patients with decompensated liver cirrhosis will be evaluated.
Read the detailed description
To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients of decompensated liver cirrhosis.
- Conditions
- Liver Cirrhosis
- Being tested
- conventional therapy plus low dose hUC-MSCs treatment, conventional therapy plus medium dose hUC-MSCs treatment, conventional therapy plus high dose hUC-MSCs treatment
- Keywords
- Decompensated Liver Cirrhosis, Umbilical Cord Mesenchymal Stem Cells
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional therapy plus low dose hUC-MSCs treatmentBiological
patients will receive the conventional therapy plus low dose hUC-MSCs treatment
conventional therapy plus medium dose hUC-MSCs treatmentBiological
patients will receive conventional therapy plus medium dose hUC-MSCs treatment
conventional therapy plus high dose hUC-MSCs treatmentBiological
patients will receive conventional therapy plus high dose hUC-MSCs treatment
| Study group | Role | What they receive |
|---|---|---|
| Conventional plus hUC-MSCs treatment (low dose) | Experimental | Not described Receives: Biological: conventional therapy plus low dose hUC-MSCs treatment |
| conventional therapy plus hUC-MSCs treatment （medium dose） | Experimental | Not described Receives: Biological: conventional therapy plus medium dose hUC-MSCs treatment |
| conventional therapy plus hUC-MSCs treatment （high dose） | Experimental | Not described Receives: Biological: conventional therapy plus high dose hUC-MSCs treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: 1 year after treatment
Secondary outcomes (5)
Liver function improvement
Measured: 1 year after treatment
The size of liver and the width of portal venous
Measured: 1 year after treatment
Incidence of hepatocellular carcinoma within 1 year
Measured: 1 year after treatment
Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL)
Measured: 1 year after treatment
The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al )
Measured: 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionOct 2011
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- No.85 Hospital, Changning, Shanghai, China
- Responsible party
- Sponsor
- Investigators
- Chengwei Chen, Principal investigator, No.85 Hospital, Changning, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342250
- Sponsor's protocol ID
- BKCR-LD-1.0(2010)
- Status last verified
- Oct 2011
- First submitted
- 21 Apr 2011
- Last updated
- 14 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ι/Π Study of Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT01342250
- Acronym / sponsor ID
- BKCR-LD-1.0(2010)
- Conditions
- Liver Cirrhosis
- Keywords
- Decompensated Liver Cirrhosis, Umbilical Cord Mesenchymal Stem Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- No.85 Hospital, Changning, Shanghai, China
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 27 Apr 2011 (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.
Although liver transplantation provide a option to cure patients suffering with decompensated liver cirrhosis this condition, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Bone marrow derived mesenchymal stem cells (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively rescued experimental liver failure and contributed to liver regeneration, which suggest the novel and promising therapeutic strategy In this study, the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSCs) transplantation for patients with decompensated liver cirrhosis will be evaluated.
Detailed description
To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients of decompensated liver cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional plus hUC-MSCs treatment (low dose) | Experimental | Biological: conventional therapy plus low dose hUC-MSCs treatment |
| conventional therapy plus hUC-MSCs treatment （medium dose） | Experimental | Biological: conventional therapy plus medium dose hUC-MSCs treatment |
| conventional therapy plus hUC-MSCs treatment （high dose） | Experimental | Biological: conventional therapy plus high dose hUC-MSCs treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent.
- Aged 18-70 years.
- Decompensated liver cirrhosis, Child-Pugh B/C (7-12 points); or Meld score≦21.
- Expecting lifetime is over 2 months.
- Hepatitis B decompensated liver cirrhosis patients need antiviral therapy.
Key exclusion criteria (9 listed)
- Severe drug allergic history or anaphylaxis.
- Severe problems in other vital organs(e.g. the heart, renal or lungs)
- Severe problems in psychiatric disease,such as Schizophrenia,et al
- Severe bacteria infection.
- Malignancies.
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 therapy plus low dose hUC-MSCs treatmentpatients will receive the conventional therapy plus low dose hUC-MSCs treatment | Biological | Conventional plus hUC-MSCs treatment (low dose) |
| conventional therapy plus medium dose hUC-MSCs treatmentpatients will receive conventional therapy plus medium dose hUC-MSCs treatment | Biological | conventional therapy plus hUC-MSCs treatment （medium dose） |
| conventional therapy plus high dose hUC-MSCs treatmentpatients will receive conventional therapy plus high dose hUC-MSCs treatment | Biological | conventional therapy plus hUC-MSCs treatment （high dose） |
Primary outcome
Overall Survival (OS)
Time frame: 1 year after treatment
5 secondary outcomes
Liver function improvement
Time frame: 1 year after treatment
The size of liver and the width of portal venous
Time frame: 1 year after treatment
Incidence of hepatocellular carcinoma within 1 year
Time frame: 1 year after treatment
Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL)
Time frame: 1 year after treatment
The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al )
Time frame: 1 year after treatment
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 14 Oct 2011.
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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.
Chengwei Chen principal investigator
No.85 Hospital, Changning, Shanghai, 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 conventional therapy plus low dose hUC-MSCs treatment, conventional therapy plus medium dose hUC-MSCs treatment and conventional therapy plus high dose hUC-MSCs treatment in people with Liver Cirrhosis, run by Shenzhen Beike Bio-Technology Co., Ltd. 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 5 inclusion and 9 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 14 Oct 2011. 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?
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?
Overall Survival (OS) (time frame: 1 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 14 Oct 2011.