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Heart regeneration therapy by autologous Adipose Tissue Derived Stromal Cells

Phase 1
Conditions
Heart failure that occurred by prior ischemic event whose ejection fraction is less than 40%
Registration Number
JPRN-jRCTb040190115
Lead Sponsor
Kaneko Shuichi
Brief Summary

Regarding the primary endpoint's safety, no adverse events were observed during the perioperative period and 6 months in all 3 patients. As secondary endpoints, the changes in cardiopulmonary function were evaluated. In one patient (case 2), maximal oxygen uptake increased, and in two patients (cases 2 and 3), exercise tolerance (6 minutes walking distance) improved. On the other hand, there was one patient (case 1) in which the cardiopulmonary function did not change.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
3
Inclusion Criteria

Heart failure that occurred by prior ischemic event whose ejection fraction is less than 40%

Exclusion Criteria

1.Complicated severe other organ disease.
2.Patients with malignancy.
3.History of chemotherapy or irradiation within 4 weeks.
4.Patients with immunodeficiency
5.Pregnancy or possibility of pregnancy
6.Candidates who are judged to be not applicable to this study by doctors.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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