Treatment Group | Low-Dose IDCT N = 20 | High-Dose IDCT N = 20 | Vehicle N = 10 | Placebo N = 10 |
Day 1 | 60.5 (13.4) | 64.9 (14.7) | 62.6 (10.0) | 63.3 (17.1) |
Week 4 | 46.8 (24.2)) | 45.2 (27.3) | 51.8 (20.9) | 45.9 (15.4 |
Week 12 | 34.8 (23.3) | 30.3 (24.8) | 40.4 (23.6) | 45.6 (16.7) |
Week 26 | 31.5 (19.9) | 32.1 (23.7) | 41.1 (18.2) | 29.6 (8.7) |
Week 52a | 36.6 (23.8) | 23.8 (21.2) | 30.0 (24.2) | 38.6 (23.9) |
Week 78 | 37.3 (24.6) | 25.9 (26.2) | 34.9 (21.5) | 31.6 (21.2) |
Week 104 | 28.1 (21.9) | 26.7 (26.6) | 25.2 (17.5) | 44.8 (18.8) |
Abbreviation: IDCT, injectable disc cell therapy.
↵a Primary endpoint (N’s = 18, 17, 9, and 7 for the 4 groups, respectively).