Table 5.
Overview of the (serious) adverse events reported following cell transplantation.
| Author | Ref | n | SAE | AE | Description | Type |
|---|---|---|---|---|---|---|
| Yoshikawa | [36] | 2 | ? | ? | - | Mesenchymal stromal cells |
| Orozco | [37] | 10 | ✘ | ? | - | |
| Centeno | [38,39] | 33 | ✘ | ✓ | Unspecified complaints (n=6) Pain (n=3) Large herniated disc (n=1) |
|
| Noriega | [40], [41], [42] | Unclear | ✘ | ✓ | Pain (n=11)* | |
| Papadimitriou | [43,44] | 10 | ✘ | ✘ | - | |
| Amirdelfan | [45,46] | 60 | ✓ | ✓ | Pain (n=34) Arthralgia (n=6) Muscle spams (n=6) Elevated CRP (n=2) Pharyngitis streptococcal (n=2) |
|
| Jung | [47] | 3 | ✓ | ✓ | Pulmonary embolism (n=3) | |
| Piccirilli | [48] | 2 | ✘ | ✘ | - | |
| Kumar | [49] | 10 | ✘ | ✘ | - | |
| Bates | [50] | 9 | ✘ | ✓ | Pain flare (n=1) | |
| Zhang | [51] | 75 | n.a. | n.a. | - | |
| Pang | [52] | 2 | ✘ | ✘ | - | |
| Meisel | [53], [54], [55] | 12 | ? | ? | - | Chondrogenic cells |
| Mochida | [56] | 9 | ✘ | ✘ | - | |
| Tschugg | [57,58] | 12 | ✓ | ✓ | Unspecified complaints (n=2) IVD protrusion (n=1) Nasal pharyngitis (n=3) |
|
| Schwan | [59] | 10 | ✓ | ✓ | Recurrent disc herniation (n=10) | |
| Beall | [60] | 16 | ✘ | ✓ | Muscle injury (n=1) RBC sediment rate increase (n=1) Pain (n=9) Burning sensation (n=1) |
|
| Hunter | [61,62] | 140 | ✓ | ✓ | Unspecified complaints (n=36) Myocardial infarction (n=1) Transient ischemic attack (n=1) Bacteremia (n=1) Osteomyelitis (n=2) Spinal osteoarthritis (n=1) Pneumonia (n=1) Pain (n=4) |
|
| Foley | [63] | 40 | ✘ | ? | - | |
| Xuan | [64] | 18 | ✓ | ✓ | Pain (n=3) Disc reherniation (n=1) |
|
| Coric | [65] | 15 | ✘ | ✘ | - | |
| Comella | [66] | 15 | ✘ | ✓ | Soreness (n=?) | Mixture of cells |
| Pettine | [67], [68], [69] | 26 | ✘ | ✓ | Pain (n=?) | |
| Wolff | [70] | 33 | ✘ | ✘ | - | |
| Ramos | [71] | 1 | ✓ | ✓ | Lumbar discitis (n=1) Osteomyelitis (n=1) |
|
| El-Kadiry | [72] | 13 | ✘ | ✘ | - | |
| Jerome | [73] | 3 | ✓ | ✓ | Pain (n=3) Constipation (n=2) Fever (n=2) Elevated CRP (n=2) Discitis (n=1) Spondylodiscitis (n=2) Epidural abscess (n=1) |
|
| Xu | [74] | 15 | ✘ | ✘ | - | |
| Subach | [75] | 1 | ✓ | ✓ | Disc extrusion (n=1) Osteomyelitis (n=1) Discitis (n=1) Epidural abscess (n=1) Cauda equina (n=1) |
|
| Haufe | [76] | 10 | ? | ? | - |
✓: AE reported, ✘: no AE reported, ?: unreported or unclear results. Abbreviations: AE – Adverse event, CRP – C-reactive protein, IVD – Intervertebral disc, N.A. – Not applicable, and SAE – Serious adverse event, RBC – Red blood cell count, and REF – Reference.