Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Shuichi Kaneko, Kanazawa University
ClinicalTrials.gov Identifier:
NCT01709279
First received: October 16, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

Mesenchymal stem cells have capability to differentiate into myocardium, vascular endothelial cell, vascular smooth muscle cell and will be useful for heart regeneration. Adipose tissue is relatively enriched with mesenchymal stem cell compared to bone marrow tissue. In this trial, eligible ischemic heart failure patients will be proceeded intracoronary administration of autologous adipose tissue derived stromal cells by cardiac catheterization.


Condition Intervention
Ischemic Heart Failure
Biological: adipose tissue derived stromal cells dosage

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

Resource links provided by NLM:


Further study details as provided by Kanazawa University:

Primary Outcome Measures:
  • all cause harmful events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 6
Study Start Date: August 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
adipose tissue derived stromal cells Biological: adipose tissue derived stromal cells dosage
intra-coronary administration of autologous adipose tissue derived stroma cells

Detailed Description:

The population of the ischemic heart failure patients is enormous in Japan and the only radical treatment for them is heart transplantation: however, the number of giving donor is extremely limited. Mesenchymal stem cells have been capable to differentiate into mesodermal-lineage cells as well as endodermal-lineage cells such as myocardial cell. 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 ischemic heart failure patients will undergo intracoronary administration of autologous adipose tissue derived stromal cells through cardiac catheterization.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heart failure patients occured by prior ischemic event whose ejection fraction must be less than 40%.

Exclusion Criteria:

  • Complicated severe other organ disease.
  • Patient with malignancy.
  • History of chemotherapy or irradiation within 4 weeks.
  • Patient with immunodeficiency
  • Pregnancy or possibility of pregnancy
  • Candidate who are judged to be not applicable to this study by doctors.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709279

Locations
Japan
Kanazawa University Hospital
Kanazawa, Ishikawa, Japan, 920-8641
Sponsors and Collaborators
Kanazawa University
  More Information

No publications provided

Responsible Party: Shuichi Kaneko, Professor, Kanazawa University
ClinicalTrials.gov Identifier: NCT01709279     History of Changes
Other Study ID Numbers: 1133
Study First Received: October 16, 2012
Last Updated: October 16, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kanazawa University:
Ischemic heart failure
Myocardial regeneration
ADRC

Additional relevant MeSH terms:
Heart Failure
Ischemia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014