Status:
UNKNOWN
Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration
Lead Sponsor:
Sakakibara Heart Institute
Collaborating Sponsors:
CellBank of Japan
Conditions:
Chronic Heart Failure
Old Myocardial Infarction
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and effectiveness of intracoronary infusion of autologous cardiac stem cells in patients with ischemic cardiomyopathy.
Detailed Description
This phase I trial will involve 6 patients suffering from chronic ischemic cardiomyopathy and congestive heart failure, to be compared with historical control subjects. This study will be conducted as...
Eligibility Criteria
Inclusion
- Adult with ability to provide informed consent.
- Left ventricular ejection fraction less than 40% as evidenced by echocardiogram.
- Scheduled for elective surgical revascularization within 2 months.
Exclusion
- Positive for HBs-Ag, HCV-Ab, HIV-Ab, or tests for syphilis.
- Diabetic HbA1c greater than 8.5%.
- Pregnant women.
- Scheduled for additional interventions including ventriculoplasty.
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03351400
Start Date
November 15 2017
End Date
March 1 2022
Last Update
March 18 2021
Active Locations (1)
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1
Sakakibara Heart Institute
Tokyo, Japan, 183-0003