Other Surgical ProceduresPhase 2/3NCT01491165
Safety and Efficacy of Stem Cell Transplantation for Treatment of Liver Cirrhosis
A Phase 2/3 study testing stem cell transplantation through interventional procedures in people with Other Surgical Procedures, run by General Hospital of Chinese Armed Police Forces at 1 site in China.
Trial summary
Mainstream of current treatment of liver cirrhosis is liver transplantation, but there are high cost, risk and immune rejection and other issues. Umbilical cord mesenchyma stem cell with self-and directed differentiation capacity can effectively rescue experimental liver failure and contribute to liver regeneration… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Other Surgical Procedures
- What is being tested?
- stem cell transplantation through interventional procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Jun 2014
- Phase
- Phase 2/3
- 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.
China1 site, 1 recruiting
- Recruiting
Yihua An
Beijing
Yihua An, doctor, 0086-10-88276848, doctoran2010@hotmail.com
About this study
Official title: Safety and Efficacy of Umbilical Cord Mesenchyma Stem Cell Transplantation in Liver Cirrhosis Patients
Mainstream of current treatment of liver cirrhosis is liver transplantation, but there are high cost, risk and immune rejection and other issues. 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 in patients liver cirrhosis will be evaluated.
Read the detailed description
This study included three research centers, each center were carried out 25 cases of liver cirrhosis in patients with stem cell transplantation. All the selection and exclusion criteria are same, data summary and analysis will be complete by the epidemiological commissioner.
- Conditions
- Other Surgical Procedures
- Being tested
- stem cell transplantation through interventional procedures
- Keywords
- umbilical cord mesenchyma stem cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cell transplantation through interventional proceduresProcedure or surgery
Also called umbilical cord mesenchyma stem cell transplantation
one time interventional procedures
| 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 procedures |
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: 3 days before transplantation, 6 and 12 months after transplantation
Secondary outcomes (7)
liver biopsy
The result of liver biopsy judged by the expert.
Measured: whinin 7 days before transplantation, 6 and 12 months after transplantation
gastroscopy
Observe and photograph the related varicose veins.
Measured: whinin 7 days before transplantation, 6 and 12 months after transplantation
blood biochemistry
- alanine aminotransferase
- aspartate aminotransferase
- gamma-glutamyltransferase(GGT)
- alkaline phosphatase
- total bilirubin
- direct bilirubin
- The total bile acid (TBA)
- serum cholinesterase (CHE)
- total cholesterol (TC)
- albumin
- the proportion of white balls
Measured: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
blood test
- platelet count (PLT)
- mean platelet volume (MPV)
- platelet distribution width (PDW)
- platelet hematocrit (PCT)
- alpha feto protein(AFP)
Measured: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
liver enzyme fiber spectrum
- laminin (LN)
- Ⅳ collagen detection (CIV)
- hyaluronic acid (HA)
- procollagen Ⅲ(PC Ⅲ)
Measured: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
coagulation
- prothrombin time (PT)
- activated partial thromboplastin time (APTT)
- fibrinogen (FIB)
- thrombin time (TT)
Measured: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
portal vein and splenic vein measure
- Portal vein diameter (Dpv);
- Portal vein maximum velocity (Vmaxpv);
- Portal vein blood flow per minute (Qpv);
- The splenic vein diameter (Dsv);
- Splenic vein maximum flow velocity (Vmaxsv);
- Splenic vein blood flow per minute (Qsv).
Measured: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Surgical ProceduresStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Chinese Armed Police Forces
- Sponsor type
- University, hospital or other
- Collaborators
- Xinjiang Armed Police Corps Hospital, Taian Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Yihua An, Study director, Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491165
- Sponsor's protocol ID
- 2011-12-07 liver cirrhosis
- Status last verified
- Oct 2012
- First submitted
- 8 Dec 2011
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Umbilical Cord Mesenchyma Stem Cell Transplantation in Liver Cirrhosis Patients
- ClinicalTrials.gov ID
- NCT01491165
- Acronym / sponsor ID
- 2011-12-07 liver cirrhosis
- Conditions
- Other Surgical Procedures
- Keywords
- umbilical cord mesenchyma stem cell
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- General Hospital of Chinese Armed Police ForcesUniversity, hospital or other
- Collaborators
- Xinjiang Armed Police Corps Hospital, Taian Hospital of Traditional Chinese Medicine
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 13 Dec 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.
Mainstream of current treatment of liver cirrhosis is liver transplantation, but there are high cost, risk and immune rejection and other issues. 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 in patients liver cirrhosis will be evaluated.
Detailed description
This study included three research centers, each center were carried out 25 cases of liver cirrhosis in patients with stem cell transplantation. All the selection and exclusion criteria are same, data summary and analysis will be complete by the epidemiological commissioner.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stem cell transplantation therapy | Experimental | Procedure: stem cell transplantation through interventional proceduresumbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients. |
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 proceduresAlso: umbilical cord mesenchyma stem cell transplantationone time interventional procedures | Procedure or surgery | stem cell transplantation therapy |
Primary outcome
liver volume calculated by MRI
Time frame: 3 days before transplantation, 6 and 12 months after transplantation
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
7 secondary outcomes
liver biopsy
Time frame: whinin 7 days before transplantation, 6 and 12 months after transplantation
gastroscopy
Time frame: whinin 7 days before transplantation, 6 and 12 months after transplantation
blood biochemistry
Time frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
blood test
Time frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
liver enzyme fiber spectrum
Time frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
coagulation
Time frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
portal vein and splenic vein measure
Time frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 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 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 2/3 study testing stem cell transplantation through interventional procedures in people with Other Surgical Procedures, 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 26 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver volume calculated by MRI (time frame: 3 days before transplantation, 6 and 12 months 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 26 Oct 2012.