Table 3.
Mean demographics and safety results
| Cohort A (n = 3) | Cohort B (n = 3) | Cohort C (n = 3) | Pooled cohort (n = 9) | |
|---|---|---|---|---|
| Age: mean (range) | 42 (30–49) | 43 (41–45) | 48 (37–54) | 44 (30–54) |
| Sex: male/female | 3/0 | 3/0 | 2/1 | 8/1 |
| NIHSS mean (SEM) | 5.3 (2.0) | 7.7 (1.2) | 6.0 (0.6) | 6.3 (0.8) |
| MRS mean (SEM) | 3.0 (0.0) | 3.0 (0.0) | 3.3 (0.3) | 3.1 (0.1) |
| FMMS mean (SEM) | 33.3 (3.0) | 33.7 (7.3) | 30.7 (9.1) | 32.6 (3.5) |
| AE/SAE/death reported | 18/2a/0 | 2/0/0 | 15/0/0 | 35b/2/0 |
a
Cholecystitis (grade 3), unrelated to surgery.
b
Thirty‐five total AEs involved seven subjects, of which 30 were resolved without sequelae, two incidences from cholecystitis were reported as having changed in status, and three continuing (#107 constipation; #108 pruritus and weight gain).
Abbreviations: AE, adverse event; FMMS, Fugl‐Meyer Motor Score; MRS, modified Rankin Score; NIHSS, National Institutes of Health Stroke Scale; SAE, serious adverse event.