Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells
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ClinicalTrials.gov Identifier: NCT00913289 |
Recruitment Status :
Terminated
First Posted : June 4, 2009
Last Update Posted : October 18, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Cirrhosis | Biological: adipose tissue derived stromal cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | April 2010 |

Arm | Intervention/treatment |
---|---|
adipose tissue derived stromal cells |
Biological: adipose tissue derived stromal cells
dosage |
- all cause harmful events [ Time Frame: 6 months ]

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Associated with risky gastroesophageal varices for bleeding
- Severe portal hypertension
- Complicated with severe heart failure
- Renal disease
- Respiratory disease
- Hematological disease
- Coagulation disturbance and judged to be excluded by doctors
- Associated with malignancy
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913289
Japan | |
Kanazawa University Hospital | |
Kanazawa, Ishikawa, Japan, 920-8641 |
Study Chair: | Shuichi Kaneko, M.D. | Kanazawa University |
Responsible Party: | Shuichi Kaneko, Professor, Kanazawa University |
ClinicalTrials.gov Identifier: | NCT00913289 |
Other Study ID Numbers: |
675 |
First Posted: | June 4, 2009 Key Record Dates |
Last Update Posted: | October 18, 2012 |
Last Verified: | October 2012 |
Liver Cirrhosis |
Liver Cirrhosis Fibrosis Pathologic Processes Liver Diseases Digestive System Diseases |