pISSN: 2671-4639
eISSN: 2671-4663
pISSN: 2671-4639
eISSN: 2671-4663
Clinical trials with hPSC-derived CPCs or cardiomyocytes
| Institution (Nation) | Assistance Publique (France) | Osaka University (Japan) | Heartseed (Japan) |
|---|---|---|---|
| Status (Term) | Phase 1 completed (2013.05.27-2018.03.22) | Phase 1 undergo (2019.12.02-2023.05.30) | Phase 1 undergo (2022.04.19-2024.03.31) |
| Target disease | Ischemic Heart Disease | Myocardial Ischemia | Heart Failure |
| Patient | 10 patients for 5 years | 10 patients for 3 years | 10 patients for 5 years |
| Cell source | ESC | Allogeneic iPSC | Allogeneic iPSC |
| Cell type | CPC (SSEA1+ IsI-1+) | Cardiomyocyte | Cardiomyocyte |
| Transplantation | 20 cm2 Fibrin patch embedding hESC-derived CPCs |
hiPSC-derived cardiomyocyte sheets | hiPSC-derived cardiomyocyte spheroids |
| Clinical mechanism | Improves heart function by releasing factors that promote myocardial and/or vascular regeneration | 1) Helps heart function through self-beating 2) Improves heart function by releasing factors that promote myocardial and/or vascular regeneration |
1) Helps heart function through self-beating 2) Improves heart function by releasing factors that promote myocardial and/or vascular regeneration |
| Outcome measures | 1 year follow-up after surgery: 1) Feasibility of patch’s generation and its efficacy on cardiac functions 2) Evidence for new clinical/biological abnormalities, occurrence of arrhythmias or development of a cardiac or extra-cardiac tumor |
1 year follow-up after surgery: 1) Left ventricular (LV) ejection fraction, contractile and remodeling of the LV, New York Heart Association functional classification 2) Serious adverse events, abnormal blood biochemical or tumor marker tests and cardiac function clinical events 3) Minnesota Living with Heart Failure Questionnaire, 36-Item Short Form Survey etc. |
1 year follow-up after surgery: 1) LV ejection fraction, myocardial wall motion evaluation, myocardial blood flow, myocardial viability 2) Safety and Tolerability 3) Kansas City Cardiomyopathy Questionnaire etc. |
| Result | 1. Cardiac function improvement effect 2. No arrhythmia, teratoma and immune-suppressant complications |
Ongoing | Ongoing |
| Pre/Clinical publication | Menasché et al., 2018 | Kashiyama et al., 2019 | Kawaguchi et al., 2021 |