|
| Study name | Study design | Study phase | Prespecified endpoint | Method of LVEF evaluation | Number of patients | Follow-up (months) | Cell type | Number of transplanted cells (million) | Cell delivery method |
|
| TOPCARE-DCM [12] (NCT00284713) | Prospective, open-label | II | (i) Absolute change in regional LV wall motion of the target area | LV angiography | 33 | 12 | BMMC | 259 ± 135 | IC |
|
| ABCD [13] (NCT unavailable) | Prospective, randomized, open-label | II | (i) Change in NYHA functional class
(ii) Change in LVEF
(iii) Mortality
(iv) Histopathologic evaluation | Echo | 44 (24 treated/20 controls) | 6 | BMMC | 28 ± 16 | IC |
|
| Bocchi et al. [14] (NCT unavailable) | Prospective, randomized, open-label | II | (i) Improvement in LVEF
(ii) Exercise capacity
(iii) QoL | Echo | 40 (23 treated/17 controls) | 1 | BMMC | Not available | IC |
|
| REGENERATE-DCM [15] (NCT01302171) | Prospective, randomized, placebo-controlled, double-blind | II | (i) Change in global LVEF at 3 months
(ii) Change in global LVEF at 12 months
(iii) Exercise capacity
(iv) QoL
(v) Change in NT-proBNP | CMR/cCT | 60 (15 peripheral G-CSF, 15 peripheral placebo, 15 IC stem cells, 15 IC serum) | 12 | BMMC | 216 ± 221 | IC |
|
| Vrtovec et al. [17] (NCT00629018) | Prospective, randomised, open-label | II | (i) Change in global LVEF at 12 months
(ii) Exercise capacity
(iii) Change in NT-proBNP | Echo | 55 (28 treated/27 controls) | 12 | HSC (CD34+) | 123 ± 23 | IC |
|
| Vrtovec et al. [18] (NCT01350310) | Prospective, randomised, open-label | II | (i) Change in global LVEF at 12 months
(ii) Exercise capacity
(iii) Change in NT-proBNP | Echo | 110 (55 treated/55 controls) | 60 | HSC (CD34+) | 113 ± 26 | IC |
|
| Vrtovec et al. [19] (no NCT number) | Prospective, randomised, open-label | II | (i) Change in global LVEF at 12 months
(ii) Exercise capacity
(iii) Change in NT-proBNP | Echo | 40 (20 IC injections/20 TE injections) | 6 | HSC (CD34+) | IC: 103 ± 27
TE: 105 ± 31 | IC/TE |
|
| Butler et al. [22] (NCT02467387) | Prospective, randomized, single-blind, placebo-controlled | II | (i) All-cause mortality
(ii) All-cause hospitalizations
(iii) Adverse events
(iv) LVEF
(v) Exercise capacity
(vi) QoL
(vii) Change in NT-proBNP | CMR | 22 (10 treated/12 placebo) | 6 | alloMSC | 1.5 million cells/kg | IV |
|
| POSEIDON-DCM [23] (NCT01392625) | Prospective, randomised, open-label | I/II | (i) Adverse events
(ii) LVEF
(iii) Exercise capacity
(iv) QoL | CMR/cCT/echo | 37 (19 alloMSC/18 autoMSC) | 12 | AlloMSC versus autoMSC | 100 | TE |
|
