Table 5.
Inflammatory markers.
| Infusion 1 (Baseline) | Infusion 2 | Infusion 3 | Infusion 4 | Regression result | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Characteristic, M (SD) | N | HB-adMSCs100MM, N = 30 | Placebo, N = 13 | N | HB-adMSCs 100MM, N = 24 | Placebo, N = 11 | N | HB-adMSCs 100MM, N = 18 | Placebo, N = 9 | N | HB-adMSCs 100MM, N = 17 | Placebo, N = 9 | Time × Group interaction PP | Group main effect PP |
| TNF-α, M (SD) | 25 | 15.5 (13.9) | 18.2 (12.3) | 19 | 26.1 (26.5) | 15.9 (10.0) | 29 | 33.4 (49.8) | 35.3 (38.8) | 24 | 20.3 (11.3) | 30.5 (40.5) | 82.6% | 57.4% |
| Interleukin-10, M (SD) | 23 | 16.3 (19.4) | 11.9 (16.6) | 19 | 18.8 (39.1) | 44.7 (98.9) | 26 | 30.8 (86.3) | 27.2 (65.1) | 13 | 13.0 (13.5) | 8.4 (10.8) | 83.9% | 91.4% |
| Interleukin-6, M (SD) | 39 | 24.3 (71.8) | 69.4 (166.5) | 29 | 46.3 (104.0) | 376.6 (988.7) | 28 | 65.4 (186.8) | 197.8 (539.7) | 26 | 35.0 (70.4) | 12.4 (23.9) | 86.3% | 52% |
| CRP, M (SD) | 37 | 4.9 (5.8) | 3.8 (5.1) | 29 | 4.8 (7.5) | 4.5 (9.2) | 21 | 3.6 (3.4) | 2.2 (4.1) | 24 | 3.5 (4.8) | 0.2 (0.2) | 78.8% | 99.5% |
HB-adMSCs 100MM, allogeneic Hope Biosciences adipose-derived MSCs 1×108 cells. TNF-α, Tumor Necrosis Factor-alpha. CRP, C-Reactive Protein. PP, posterior probability. For inflammatory markers (efficacy), regression results (posterior probabilities) were derived from Bayesian models evaluating changes over time (infusions 1 through 4) in each group (see Supplementary Data in Supplementary material for descriptions of Bayesian methods). Boldface PP values indicated PP ≥ 75%.