Liver CirrhosisPhase 1NCT00913289
Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells
A Phase 1 study testing adipose tissue derived stromal cells in people with Liver Cirrhosis, run by Kanazawa University at 1 site in Japan.
Trial summary
Mesenchymal stem cells have the capability to differentiate into hepatocytes and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cells compared to bone marrow tissue. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- adipose tissue derived stromal cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2009to Apr 2010
- Phase
- Phase 1
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver cirrhosis patients
- Platelets count in peripheral blood: over 7.0x10^4/microliter
- Serum creatinine: less than 1.5 mg/dl
- Capable of understanding the features of this clinical trial
Who cannot join
- Associated with risky gastroesophageal varices for bleeding
- Severe portal hypertension
- Complicated with severe heart failure
- Renal disease
- Respiratory disease
- Hematological disease
Show all 20Show fewer
- Coagulation disturbance and judged to be excluded by doctors
- Associated with malignancy
- Past history of the following:
- malignancy
- ischemic heart disease
- cerebrovascular disease (cerebral infarction, cerebral hemorrhage)
- decompensated status of liver cirrhosis
- Pregnant, or possibility of pregnancy
- Infected with HIV
- Under mediation with adrenal corticoid steroid, anti-histamine drug
- Anticipated with difficulty of follow-up observation
- Anticipated with inconsistency of following the protocol
- Addiction of alcohol drinking and unable to stop drinking
- Other candidates who are judged to be not applicable to this study by doctors
Trial locations and contacts
1 site in 1 country.
About this study
Mesenchymal stem cells have the capability to differentiate into hepatocytes and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cells compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive autologous adipose tissue derived stromal cells which include such mesenchymal stem cells.
Read the detailed description
The population of the liver cirrhosis patients is enormous in Japan and the only radical treatment for them is liver transplantation. However, the number of giving donors is extremely limited. Mesenchymal stem cells have been capable to differentiate into mesodermal-lineage cells as well as endodermal-lineage cells such as hepatocytes. They reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. The latter tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. In this study, the cirrhotic patients will receive autologous adipose tissue derived stromal cells which contains substantial number of mesenchymal stem cells.
- Conditions
- Liver Cirrhosis
- Being tested
- adipose tissue derived stromal cells
- Keywords
- Liver Cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adipose tissue derived stromal cellsBiological
dosage
| Study group | Role | What they receive |
|---|---|---|
| adipose tissue derived stromal cells | Other | Not described Receives: Biological: adipose tissue derived stromal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause harmful events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2010
- Study completionApr 2010
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanazawa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuichi Kaneko, Kanazawa University
- Investigators
- Shuichi Kaneko, M.D., Study chair, Kanazawa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913289
- Sponsor's protocol ID
- 675
- Status last verified
- Oct 2012
- First submitted
- 3 Jun 2009
- Last updated
- 18 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells
- ClinicalTrials.gov ID
- NCT00913289
- Acronym / sponsor ID
- 675
- Conditions
- Liver Cirrhosis
- Keywords
- Liver Cirrhosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Kanazawa UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 4 Jun 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.
Mesenchymal stem cells have the capability to differentiate into hepatocytes and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cells compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive autologous adipose tissue derived stromal cells which include such mesenchymal stem cells.
Detailed description
The population of the liver cirrhosis patients is enormous in Japan and the only radical treatment for them is liver transplantation. However, the number of giving donors is extremely limited. Mesenchymal stem cells have been capable to differentiate into mesodermal-lineage cells as well as endodermal-lineage cells such as hepatocytes. They reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. The latter tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. In this study, the cirrhotic patients will receive autologous adipose tissue derived stromal cells which contains substantial number of mesenchymal stem cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adipose tissue derived stromal cells | Other | Biological: adipose tissue derived stromal cells |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Liver cirrhosis patients
- Platelets count in peripheral blood: over 7.0x10^4/microliter
- Serum creatinine: less than 1.5 mg/dl
- Capable of understanding the features of this clinical trial
Key exclusion criteria (20 listed)
- Associated with risky gastroesophageal varices for bleeding
- Severe portal hypertension
- Complicated with severe heart failure
- Renal disease
- Respiratory disease
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 |
|---|---|---|
| adipose tissue derived stromal cellsdosage | Biological | adipose tissue derived stromal cells |
Primary outcome
all cause harmful events
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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.
Shuichi Kaneko, M.D. study chair
Kanazawa 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 study testing adipose tissue derived stromal cells in people with Liver Cirrhosis, run by Kanazawa University at 1 site in Japan.
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 4 inclusion and 20 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: stopped early, as of the sponsor's last update on 18 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 Japan. 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 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.
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 was stopped early. Results are not available in the source record.
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?
all cause harmful events (time frame: 6 months). 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 18 Oct 2012.