Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cirrhosis |
Biological: adipose tissue derived stromal cells |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells |
- all cause harmful events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 6 |
| Study Start Date: | February 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| adipose tissue derived stromal cells |
Biological: adipose tissue derived stromal cells
dosage
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Shuichi Kaneko, Professor, Kanazawa University |
| ClinicalTrials.gov Identifier: | NCT00913289 History of Changes |
| Other Study ID Numbers: | 675 |
| Study First Received: | June 3, 2009 |
| Last Updated: | October 16, 2012 |
| Health Authority: | Japan: Institutional Review Board |
Keywords provided by Kanazawa University:
|
Liver Cirrhosis |
Additional relevant MeSH terms:
|
Liver Cirrhosis Fibrosis Liver Diseases Digestive System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013