Table 1.
Baseline Characteristics of Randomized Subjects
| Allo-MSCs (n = 14) | Placebo (n = 17) | |
|---|---|---|
| Demographics | ||
| Age | 54.7 ± 12.8 | 58.2 ± 11.2 |
| Female | 8 (57) | 13 (76) |
| Race | ||
| White | 8 (57) | 13 (76) |
| Black | 4 (29) | 3 (18) |
| Other | 2 (14) | 1 (6) |
| Hispanic | 1 (8) | 3 (19) |
| Physical findings and risk factors | ||
| Body mass index, kg/m2 | 30.2 ± 9.0 | 30.4 ± 6.5 |
| Heart rate, beats/min | 74.4 ± 9.0 | 76.1 ± 11.2 |
| SBP, mm Hg | 118.6 ± 21.6 | 115.4 ± 11.0 |
| DBP, mm Hg | 68.9 ± 18.6 | 67.1 ± 11.2 |
| Diabetes | 3 (21) | 5 (29) |
| Hypertension | 6 (43) | 10 (59) |
| Smoking (lifetime) | 5 (36) | 3 (18) |
| Cardiovascular history | ||
| Left ventricular ejection fraction | 33.7 ± 3.4 | 32.5 ± 6.5 |
| Previous hospitalization for heart failure | 7 (50) | 8 (47) |
| Previous emergency department visit for heart failure | 4 (29) | 3 (18) |
| Time since AIC diagnosis, yrs | 6.1 ± 5.9 | 8.7 ± 5.0 |
| New York Heart Association functional class II | 13 (93) | 13 (76) |
| New York Heart Association functional class III | 1 (7) | 4 (24) |
| Device present | 6 (43) | 12 (71) |
| Pacemaker | 0 (0) | 0 (0) |
| Implantable cardioverter-defibrillator | 5 (36) | 8 (47) |
| Biventricular pacing alone | 0 (0) | 0 (0) |
| Biventricular pacing and ICD | 1 (7) | 4 (24) |
| Angina | 1 (7) | 1 (6) |
| Percutaneous coronary intervention/coronary artery bypass graft | 0 (0) | 0 (0) |
| Atrial fibrillation | 3 (21) | 5 (29) |
| Sustained ventricular arrhythmia | 5 (36) | 7 (41) |
| Oncological history | ||
| Leukemia | 3 (21) | 0 (0) |
| Breast cancer | 6 (43) | 9 (53) |
| Hodgkin's disease | 0 (0) | 1 (6) |
| Non-Hodgkin's lymphoma | 1 (7) | 5 (29) |
| Sarcomas | 1 (7) | 0 (0) |
| Multiple cancers | 3 (21) | 2 (12) |
| Antineoplastic Treatment | ||
| Anthracyclines | ||
| Doxorubicin | 11 (79) | 17 (100) |
| Epirubicin | 1 (7) | 0 (0) |
| Daunorubicin | 2 (14) | 0 (0) |
| AIC exposure, mg/m2∗ | 353.0 ± 351.3 | 339.5 ± 113.6 |
| Other potential cardiotoxic agents | ||
| Her2-directed therapy | 1 (7) | 1 (6) |
| Tyrosine kinase inhibitors | 0 (0) | 0 (0) |
| Other chemotherapies | ||
| Cyclophosphamide | 4 (29) | 3 (18) |
| Cytoxan | 4 (29) | 6 (35) |
| Paclitaxel | 3 (21) | 3 (18) |
| Docetaxel | 1 (7) | 2 (12) |
| Other | 6 (43) | 8 (47) |
| Time from cancer diagnosis, yrs† | 16.4 ± 9.5 | 18.8 ± 8.5 |
| Time from last anthracycline treatment, yrs | 13.3 ± 9.3 | 16.8 ± 7.6 |
| Radiation history | ||
| Total who had radiation | 9 (64) | 12 (71) |
| Whole breast | 3 (21) | 0 (0) |
| Partial breast | 1 (7) | 1 (6) |
| Post-mastectomy chest wall | 2 (14) | 2 (12) |
| Internal mammary field | 0 (0) | 0 (0) |
| Axillary | 1 (7) | 2 (12) |
| Mantle | 0 (0) | 1 (6) |
| Radiation field included left chest | 2 (14) | 2 (12) |
| Medications | ||
| Aspirin | 7 (50) | 5 (29) |
| Beta-blockers | 13 (93) | 16 (94) |
| Angiotensin-converting enzyme inhibitors/angiotensin II blockers/angiotensin receptor-neprilysin inhibitors | 12 (86) | 15 (88) |
| Aldosterone antagonists | 9 (64) | 10 (59) |
| Calcium-channel blockers | 1 (7) | 0 (0) |
| Hydralazine | 0 (0) | 1 (6) |
| Nitrates | 0 (0) | 2 (12) |
| Statins | 5 (36) | 8 (47) |
| Diuretics | 9 (64) | 14 (82) |
| Anticoagulants | 2 (14) | 4 (24) |
Values are mean ± SD or n (%).
AIC = anthracycline-induced cardiomyopathy; Allo-MSC = allogeneic mesenchymal stromal cells.
∗
Anthracycline dose information only available for a subset of cohort.
†
Time from earliest diagnosis requiring anthracycline treatment (n = 20)