Table 1.
Overview of safety analysis regarding thromboembolic safety and mortality, immunological as well as oncological safety
| Thromboembolic safety and mortality | ||||||
|---|---|---|---|---|---|---|
| Author | Study type | Administration route | Cell type | TE complications | Mortality | Follow‐up |
| Cardiac | ||||||
| Comella et al. [73] | Case series | Transendocardial | ADRC | 1/28 | 3/28 | 6 |
| Henry et al. [76] | RCT | Intramyocardial | ADRC | 3/17 (1/14) | 2/17 (0/14) | 12 |
| Houtgraaf et al. [74] | RCT | Intracoronary | ADRC | – | – | 6 |
| Perin et al. [75] | RCT | Transendocardial | ADRC | 1/21 (1/6) | 3/21 (2/6) | 36 |
| Immunological | ||||||
| Vanikar et al. [82] | RCT | Intravenous | alloASC | 6/95 (9/190) | 7/95 (20/190) | 6 |
| Fang et al. [81] | Case series | Intravenous | alloASC | 0/6 | 2/6 | 40 |
| Fang et al. [83] | Case series | Intravenous | alloASC | 0/7 | 0/7 | 8 |
| Pulmonary | ||||||
| Zheng et al. [84] | RCT | Intravenous | alloASC | 0/6 (0/6) | 1/6 (2/6) | 1 |
| Rheumatological | ||||||
| Álvares Garcia et al. [61] | RCT | Intravenous | alloASC | 1/46 (0/7) | 0/46 (0/7) | 6 |
| Immunological safety | ||||||
|---|---|---|---|---|---|---|
| Author | Study type | Administration route | Cell type | Complications | Biochemical reaction | Follow‐up |
| Gastrointestinal | ||||||
| Park et al. [45] | Case series | Wall of fistula | alloASC | 0/6 | CD4/CD8: N.s.i. | 6 |
| Panés et al. [44] | RCT | Wall of fistula | alloASC | N.d. | ASC/HLA‐I: 34% | 6 |
| Garcia‐Arranz et al. [39] | Case series | Wall of fistula | alloASC | 0/10 | Cytokine/US: N.s.i. | 12 |
| De la Portilla et al. [38] | Case series | Wall of fistula | alloASC | Fever: 1/24 | – | 4 |
| Immunological | ||||||
| Fang et al. [83] | Case series | Intravenous | alloASC | 0/7 | – | 8 |
| Fang et al. [81] | Case series | Intravenous | alloASC | 0/6 | – | 40 |
| Vanikar et al. [82] | RCT | Intravenous | alloASC | N.d. | – | 6 |
| Muskuloskeletal | ||||||
| Lee et al. [55] | Case series | Intratendinous | alloASC | 0/12 | CD4/CD8: N.s.i. | 12 |
| Ophthalmological | ||||||
| Oner et al. [86] | Case series | Subretinal | alloASC | 0/11 | – | 6 |
| Pulmonary | ||||||
| Zheng et al. [84] | RCT | Intravenous | alloASC | 0/6 (0/6) | – | 1 |
| Rheumatological | ||||||
| Álvaro‐Gracia et al. [61] | RCT | Intravenous | alloASC |
Fever: 9/46 (0/7) Infections: 20/46 (0/7) Rash: 2/46 (0/7) |
ASC/HLA‐I: 19%. | 6 |
| Oncological Safety | ||||||
|---|---|---|---|---|---|---|
| Author | Study type | Administration route | Cell type | Local recurrence | Metastasis | Follow‐up |
| Soft tissue, breast | ||||||
| Aronowitz et al. [19] | Case series | Subcutaneous | ADRC | 1/54 | 0/54 | 12 |
| Pérez‐Cano et al. [27] | Case series | Subcutaneous | ADRC | 0/67 | 1/67 | 12 |
| Urogenital | ||||||
| Choi et al. [72] | Case series | Transurethral | ADRC | 0/6 | 0/6 | 3 |
| Gotoh et al. [68] | Case series | Periurethral | ADRC | 0/9 | 0/9 | 6 |
| Haahr et al. [70] | Case series | Corpus cavernosum | ADRC | 0/17 | 0/17 | 6 |
Abbreviations: –, not described/not performed; CD4/CD8, CD4 to CD8 ratio; N.d., no difference in adverse events between groups. no immunological adverse events; N.s.i., no sign of immune rejection; alloASC, allogeneic ASC; ASC/HLA‐I, ASC‐specific anti‐HLA‐I antibodies; Cell type, ADRC were autologous in all cases; cytokine/US, cytokine and unspecific antibodies. Data shown as treatment group count/total (control count/total); mortality, all‐cause mortality; TE, thromboembolic.