Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells

Kanazawa University

Status and phase

Terminated

Phase 1

Conditions

Liver Cirrhosis

Treatments

Biological: adipose tissue derived stromal cells

Study type

Interventional

Funder types

Other

Identifiers

NCT00913289

675

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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