D017202
Conditions
Keywords
Coronary artery bypass, Ischemic cardiomyopathy, Adipose-derived mesenchymal stem cells, Regenerative medicine, Spray method
Brief summary
Ischemic cardiomyopathy undergoing coronary artery bypass surgery
Interventions
BIOLOGICALADR-002K administration
ADR-002K administration
Sponsors
Rohto Pharmaceutical Co., Ltd.
Osaka University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who are clinically diagnosed with ischemic cardiomyopathy and receive CABG 2. Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent 3. Others
Exclusion criteria
1. Patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure 2. Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator 3. Others
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse event | 26 weeks | Safety assessment related to adverse events and this product |
| Amount of change in late gadolinium contrast-enhanced area at the time of screening and 6 months after surgery | 26 weeks | Efficacy (Exploratory) |
| Number of complication associated with drug administration method | 26 weeks | Feasibility of drug administration method |
Countries
Japan
Contacts
Primary ContactDaisuke Mori, Ph.D
Backup ContactMasao Sasai, Ph.D
Outcome results
None listed