Table 2.
Doses of hiPSC reported in current human clinical trials for cardiac regenerative therapies.
| Trial Number | Dose | Disease | Description | Phase | Start/End |
|---|---|---|---|---|---|
| NCT03759405 | Not specified | CHF | Autologous iPS-CMs via vein transplantation | 2–3 | December 2022/ December 2024 |
| NCT03763136 | 200 M | CHF | Injection of allogenic hPSC-CM during coronary artery bypass surgery | 1–2 | October 2021/ July 2023 |
| NCT04396899 | Not specified | HFrEF (EF < 35%) | Engineered heart muscle | 1–2 | February 2020/ October 2024 |
| NCT05068674 | 10 M/150 M/300 M | Chronic ischemic LV dysfunction | Dose tolerance study of hESC-CMs | 1 | March 2022/October 2025 |
| NCT04982081 | 100 M/400 M | Congestive HF, CVD, dilated Cardiomyopathy | hiPSC-CMs catheter injection | 1 | September 2021/ July 2023 |
|
NCT04696328/ jRCT2053190081 [67] |
(3) sheets of 33 M /sheet | Ischemic cardiomyopathy | Allogenic iPSC-CM within a cell sheet | 1 | December 2019/May 2023 |
CHF = chronic heart failure, CVD = cardiovascular disease, HFrEF = heart failure with reduced ejection fraction, MI = myocardial infarction/ischemia, LV = left ventricle, EF = ejection fraction; M = million.