Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells

Liver Cirrhosis Clinical Trial

Official title:

Liver Regeneration Therapy Using Autologous Adipose Tissue Derived Stromal Cells

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00913289
• Other study ID #: 675
• Status: Terminated
• Phase: Phase 1
• First received: June 3, 2009
• Last updated: October 16, 2012
• Start date: February 2009
• Est. completion date: April 2010

Study information

• Verified date: October 2012
• Source: Kanazawa University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical 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. In this trial, eligible liver cirrhosis patients will receive autologous adipose tissue derived stromal cells which include such mesenchymal stem cells.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

Biological:
• adipose tissue derived stromal cells
dosage

Locations

Country	Name	City	State
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa

Sponsors (1)

Lead Sponsor	Collaborator
Kanazawa University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause harmful events		6 months	Yes