Table 4.
Coagulation parameters.
| Infusion 1 (Baseline) | Infusion 2 | Infusion 3 | Infusion 4 | Regression result | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Characteristic, M (SD) | N | HB-adMSCs100MM, N = 30 | Placebo, N = 13 | N | HB-adMSCs100MM, N = 24 | Placebo, N = 11 | N | HB-adMSCs100MM, N = 18 | Placebo, N = 9 | N | HB-adMSCs 100MM, N = 17 | Placebo, N = 9 | Time x Group interaction p | Group main effect p |
| WBC (x103/uL) | 42 | 11.3 (10.5) | 10.3 (3.6) | 34 | 13.5 (11.3) | 13.8 (8.7) | 27 | 12.1 (5.8) | 12.7 (5.5) | 23 | 10.4 (5.0) | 11.4 (5.8) | 0.624 | 0.787 |
| Lymphocytes (%) | 42 | 11.3 (8.2) | 12.1 (7.9) | 33 | 14.5 (13.9) | 17.2 (12.7) | 27 | 17.4 (13.3) | 16.8 (13.5) | 21 | 17.0 (11.8) | 25.7 (14.2) | 0.017 | 0.542 |
| Platelets (x103/uL) | 40 | 237.5 (98.8) | 304.8 (101.1) | 34 | 258.2 (115.7) | 295.8 (109.0) | 26 | 273.1 (119.6) | 323.1 (101.2) | 22 | 245.2 (110.5) | 303.8 (86.5) | 0.936 | 0.161 |
| Neutrophils (%) | 42 | 79.4 (15.4) | 80.7 (11.3) | 33 | 77.0 (15.3) | 75.3 (15.9) | 27 | 73.5 (15.6) | 75.7 (16.6) | 21 | 75.1 (13.3) | 66.2 (17.2) | 0.056 | 0.959 |
| Prothrombin INR | 36 | 1.2 (0.3) | 1.1 (0.1) | 29 | 1.2 (0.3) | 1.1 (0.1) | 26 | 1.2 (0.4) | 1.1 (0.1) | 21 | 1.4 (0.6) | 1.1 (0.2) | 0.573 | 0.032 |
| PT (sec) | 36 | 14.3 (3.9) | 12.9 (2.0) | 29 | 14.4 (3.1) | 13.9 (2.0) | 26 | 15.3 (4.1) | 14.6 (1.4) | 21 | 16.1 (5.8) | 14.3 (1.7) | 0.878 | 0.192 |
| PTT (sec) | 18 | 31.6 (6.6) | 29.8 (4.2) | 14 | 32.2 (5.8) | 26.5 (6.4) | 4 | 31.0 (6.9) | NA | 8 | 24.5 (12.7) | 28.2 (1.4) | 0.567 | 0.076 |
HB-adMSCs 100MM, allogeneic Hope Biosciences adipose-derived MSCs 1×108 cells. TNF-α, Tumor Necrosis Factor-alpha. CRP, C-Reactive Protein. For coagulation parameters (safety and tolerability), regression results (p values) were derived from frequentist models evaluating changes over time (infusions 1 through 4) in each group. Boldface p-values indicated p <0.05.