Table 2.
Adverse events (AEs) in each TC and in the entire study population (all TCs)
| Treatment cohort (TC) | |||||
|---|---|---|---|---|---|
| TC-A (0.7 × 106 ± 10% cells/kg) | TC-B (1.4 × 106 ± 10% cells/kg) | TC-C (2.8 × 106 ± 10% cells/kg) | TC-D (5.7 × 106 ± 10% cells/kg) | All TCs | |
| (n = 3) | (n = 3) | (n = 3) | (n = 3) | (n = 12) | |
| Number of AEs (%) | 14 (31.8) | 16 (36.4) | 9 (20.4) | 5 (11.4) | 44 |
| Short-term and mid-term AEs (within 14 days from hfNPC transplantation) | |||||
| 6 (60) | 1 (10) | 3 (30) | 0 | 10 | |
| Headache | 2a | 0 | 1a | 0 | 3 |
| Neck pain | 1a | 0 | 0 | 0 | 1 |
| Muscle stiffness | 1a | 0 | 1a | 0 | 2 |
| Hypomagnesemia | 1b | 0 | 0 | 0 | 1 |
| Constipation | 1b | 0 | 0 | 0 | 1 |
| Herpes labialis | 0 | 0 | 1b | 0 | 1 |
| Flu | 0 | 1b | 0 | 0 | 1 |
| Long-term AEs (between 15 days and 96 weeks from hfNPC transplantation) | |||||
| 8 (23.4) | 15 (44.1) | 6 (17.6) | 5 (14.7) | 34 | |
| Gastritis | 1c | 2c | 0 | 1c | 4 |
| Urinary tract infection | 1c | 1c | 0 | 1c | 3 |
| Upper respiratory tract infection | 4c | 3c | 3c | 0 | 10 |
| Hypertransaminasemia | 0 | 2c | 0 | 0 | 2 |
| Skin infection | 0 | 1c | 0 | 0 | 1 |
| Renal colic | 0 | 0 | 0 | 1c | 1 |
| Creatinine increase | 1c | 1c | 0 | 0 | 2 |
| Accidental fall | 0 | 3d | 0 | 0 | 3 |
| Hyperglycemia | 0 | 0 | 1d | 0 | 1 |
| Anemia | 0 | 0 | 0 | 1d | 1 |
| Phlebitis | 0 | 0 | 2c | 0 | 2 |
| MS relapse | 0 | 1d (SAE) | 0 | 0 | 1 |
| Intestinal polyp | 0 | 1d | 0 | 0 | 1 |
| Renal angiomyolipoma | 1d | 0 | 0 | 0 | 1 |
| Constipation | 0 | 0 | 0 | 1c | 1 |
| Causality of AEs to hfNPC | |||||
| Definetely related | 0 | 0 | 0 | 0 | 0 |
| Probably related | 4 | 0 | 2 | 0 | 6 |
| Possibly related | 2 | 1 | 1 | 0 | 4 |
| Unlikely related | 7 | 10 | 5 | 4 | 26 |
| Not related | 1 | 5 | 1 | 1 | 8 |
| Causality of SAE to hfNPCs | |||||
| Not related | 0 | 1 | 0 | 0 | 1 |
a probably related
b possibly related
c unlikely related
d not related