Liver CirrhosisPhase 1/2NCT01718587
Difference in Efficacy Between Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients
A Phase 1/2 study testing stem cell transplantation through interventional procedure and antiviral therapy (lamivudine, other antiviral drugs) in people with Liver Cirrhosis, run by General Hospital of Chinese Armed Police Forces at 1 site in China.
Trial summary
The current treatment methods of liver cirrhosis are limited ,including antiviral therapy,supportive therapy and liver transplantation. Antiviral therapy and Supportive therapy especially the regularly intravenous infusions of plasma or albumin are combined in the clinical classical therapy treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- stem cell transplantation through interventional procedure and antiviral therapy (lamivudine, other antiviral drugs)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Jul 2014
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of liver cirrhosis;
- Without hepatic encephalopathy;
- No ascites or have easily dissipated ascites;
- Value of bilirubin is less than 100;
- Value of albumin is greater than 16 g / L;
- Prothrombin time is less than 21 seconds;
Who cannot join
- Severe cardiovascular disease, and immunocompromised patients;
- Patients with localized lesions affecting graft infection;
- Coagulation disorders;
- Liver nodules more than 2cm or Liver cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Difference in Efficacy Between Umbilical Cord Mesenchyma Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients
The current treatment methods of liver cirrhosis are limited ,including antiviral therapy,supportive therapy and liver transplantation. Antiviral therapy and Supportive therapy especially the regularly intravenous infusions of plasma or albumin are combined in the clinical classical therapy treatment. In the other hand,umbilical cord mesenchyma stem cell with self and directed differentiation capacity can effectively rescue experimental liver failure and contribute to liver regeneration, which suggests the feasibility of stem cell transplantation therapy. In this study, the safety and efficacy of umbilical cord mesenchyma stem cell transplantation through interventional procedures and classical therapy in patients liver cirrhosis will be evaluated and compared.
Read the detailed description
This study will includ two research centers, the number of patients in transplantation group will be 30, the number of patients in classical therapy group will be 30. All the inclusion and exclusion criteria will be same and the data analysis will be complete by the epidemiological commissioner.
- Conditions
- Liver Cirrhosis
- Being tested
- stem cell transplantation through interventional procedure, antiviral therapy (lamivudine, other antiviral drugs)
- Keywords
- umbilical cord mesenchyma stem cell, liver cirrhosis, antiviral therapy
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cell transplantation through interventional procedureProcedure or surgery
Also called UCMSC transplantation
interventional procedure once
antiviral therapy (lamivudine, other antiviral drugs)Drug
Also called lamivudine or other antiviral drugs.
lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).
| Study group | Role | What they receive |
|---|---|---|
| stem cell transplantation therapy | Experimental | umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients. Receives: Procedure: stem cell transplantation through interventional procedure |
| antiviral therapy | Active comparator | Antiviral therapy: lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).
Supportive therapy are allowed to use on patients not including intravenous infusions of plasma or albumin. Receives: Drug: antiviral therapy (lamivudine, other antiviral drugs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver volume calculated by MRI
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
Measured: baseline
change from baseline in liver volume calculated by MRI at 6 months
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
Measured: 6 months after treatment
change from baseline in liver volume calculated by MRI at 12 months
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
Measured: 12 months after treatment
Secondary outcomes (6)
blood biochemistry
- alanine aminotransferase
- aspartate aminotransferase
- gamma-glutamyltransferase(GGT)
- alkaline phosphatase
- total bilirubin
- direct bilirubin
- The total bile acid (TBA)
- albumin
- the proportion of white balls
Measured: baseline, 1,3,6 and 12 months after treatment or transplantation
blood test
- platelet count (PLT)
- mean platelet volume (MPV)
- platelet distribution width (PDW)
- platelet hematocrit (PCT)
- alpha feto protein (AFP)
Measured: baseline,1,3,6 and 12 months after treatment or transplantation
liver enzyme fiber spectrum
- laminin (LN)
- Ⅳ collagen detection (CIV)
- hyaluronic acid (HA)
- procollagen Ⅲ(PC Ⅲ)
Measured: baseline,1,3,6 and 12 months after treatment or transplantation
coagulation
- prothrombin time (PT)
- activated partial thromboplastin time (APTT)
- fibrinogen (FIB)
- thrombin time (TT)
Measured: baselin,1,3,6 and 12 months after treatment or transplantation
portal vein and splenic vein measure
1)Portal vein diameter (Dpv) 2）Portal vein maximum velocity (Vmaxpv) 3）Portal vein blood flow per minute (Qpv) 4) The splenic vein diameter (Dsv) 5) Splenic vein maximum flow velocity (Vmaxsv) 6) Splenic vein blood flow per minute (Qsv)
Measured: baseline,1,3,6 and 12 months after treatment or transplantation
estrogen and progestin in blood
estrogen and progestin
Measured: baseline,1,3,6 and 12 months after treatment or transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013 (estimated)
- Study completionJul 2014 (estimated)
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Chinese Armed Police Forces
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Hebei Medical University
- Responsible party
- Sponsor
- Investigators
- Yihua An, PhD, Study director, Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718587
- Sponsor's protocol ID
- 2012-10-09 TC liver cirrhosis
- Status last verified
- Oct 2012
- First submitted
- 25 Oct 2012
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference in Efficacy Between Umbilical Cord Mesenchyma Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients
- ClinicalTrials.gov ID
- NCT01718587
- Acronym / sponsor ID
- 2012-10-09 TC liver cirrhosis
- Conditions
- Liver Cirrhosis
- Keywords
- umbilical cord mesenchyma stem cell, liver cirrhosis, antiviral therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- General Hospital of Chinese Armed Police ForcesUniversity, hospital or other
- Collaborators
- The First Hospital of Hebei Medical University
- Study start
- Nov 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 31 Oct 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.
The current treatment methods of liver cirrhosis are limited ,including antiviral therapy,supportive therapy and liver transplantation. Antiviral therapy and Supportive therapy especially the regularly intravenous infusions of plasma or albumin are combined in the clinical classical therapy treatment. In the other hand,umbilical cord mesenchyma stem cell with self and directed differentiation capacity can effectively rescue experimental liver failure and contribute to liver regeneration, which suggests the feasibility of stem cell transplantation therapy. In this study, the safety and efficacy of umbilical cord mesenchyma stem cell transplantation through interventional procedures and classical therapy in patients liver cirrhosis will be evaluated and compared.
Detailed description
This study will includ two research centers, the number of patients in transplantation group will be 30, the number of patients in classical therapy group will be 30. All the inclusion and exclusion criteria will be same and the data analysis will be complete by the epidemiological commissioner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stem cell transplantation therapy | Experimental | Procedure: stem cell transplantation through interventional procedureumbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients. |
| antiviral therapy | Active comparator | Drug: antiviral therapy (lamivudine, other antiviral drugs)Antiviral therapy: lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose). Supportive therapy are allowed to use on patients not including intravenous infusions of plasma or albumin. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of liver cirrhosis;
- Without hepatic encephalopathy;
- No ascites or have easily dissipated ascites;
- Value of bilirubin is less than 100;
- Value of albumin is greater than 16 g / L;
Key exclusion criteria (4 listed)
- Severe cardiovascular disease, and immunocompromised patients;
- Patients with localized lesions affecting graft infection;
- Coagulation disorders;
- Liver nodules more than 2cm or Liver cancer.
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 |
|---|---|---|
| stem cell transplantation through interventional procedureAlso: UCMSC transplantationinterventional procedure once | Procedure or surgery | stem cell transplantation therapy |
| antiviral therapy (lamivudine, other antiviral drugs)Also: lamivudine or other antiviral drugs.lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose). | Drug | antiviral therapy |
Primary outcome
liver volume calculated by MRI
Time frame: baseline
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
change from baseline in liver volume calculated by MRI at 6 months
Time frame: 6 months after treatment
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
change from baseline in liver volume calculated by MRI at 12 months
Time frame: 12 months after treatment
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
6 secondary outcomes
blood biochemistry
Time frame: baseline, 1,3,6 and 12 months after treatment or transplantation
blood test
Time frame: baseline,1,3,6 and 12 months after treatment or transplantation
liver enzyme fiber spectrum
Time frame: baseline,1,3,6 and 12 months after treatment or transplantation
coagulation
Time frame: baselin,1,3,6 and 12 months after treatment or transplantation
portal vein and splenic vein measure
Time frame: baseline,1,3,6 and 12 months after treatment or transplantation
estrogen and progestin in blood
Time frame: baseline,1,3,6 and 12 months after treatment or transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
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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.
Yihua An, PhD study director
Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force
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 stem cell transplantation through interventional procedure and antiviral therapy (lamivudine, other antiviral drugs) in people with Liver Cirrhosis, run by General Hospital of Chinese Armed Police Forces 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 6 inclusion and 4 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 31 Oct 2012. 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 Yihua An, PhD (0086-10-57976845, doctoran2010@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver volume calculated by MRI (time frame: baseline). The study lists 3 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 31 Oct 2012.