Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells

Phase 1

Terminated

• Conditions: Liver Cirrhosis
• Interventions: Biological: adipose tissue derived stromal cells

• Registration Number: NCT00913289
• Lead Sponsor: Kanazawa University

Brief 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. 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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-16
• Last Update Posted: 2012-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adipose tissue derived stromal cells	adipose tissue derived stromal cells	-

Primary Outcome Measures

Name	Time	Method
all cause harmful events	6 months

Trial Locations

Locations (1)

Kanazawa University Hospital; 🇯🇵 Kanazawa, Ishikawa, Japan