Table 1.
Effect of bone marrow mesenchymal stromal cells dose on clinical outcomes and MRI synovitis and established systemic biomarkers
| Outcome | Effect estimate, p value a | Effect estimate, p value a | Effect estimate, p value a |
|---|---|---|---|
| 1 vs. 10 million | 1 vs. 50 million | 10 vs. 50 million | |
| MRI synovitis | −0.700, p = .304 | −1.828, p = .002 | −1.128, p = .080 |
| Plasma HA | 0.127, p = .180 | 0.015, p = .870 | −0.112, p = .210 |
| Plasma COMP | −0.011, p = .747 | −0.001, p = .980 | 0.010, p = .784 |
| Serum C1‐2Cb | −0.020, p = .625 | −0.176, p = .002 | −0.156, p = .007 |
| Urine CTXII | −0.148, p = .008 | −0.026, p = .694 | 0.122, p = .018 |
| Urine C2Cb | −0.112, p ≤ .001 | −0.071, p = .035 | 0.040, p = .231 |
General estimating equation (GEE) with outcomes being changes in biomarkers (relative to baseline, delta) and predictors adjusting for dose and time.
Bolded values indicate statistical significance.
Nominal p values shown.
GEE adjusted for dose, time, and sex, as sex was found to be a significant predictor (p < .01). Hyperbolic power (α = 1) and Gpower transformations were used as indicated in supplemental online Table 9, as per Tsai et al. 50.
Abbreviations: C1‐2C, collagen type I and II cleavage; C2C, cleavage product specific to type II collagen; COMP, cartilage oligomeric matrix protein; CTXII, C‐terminal crosslinked telopeptide type II collagen; HA, hyaluronan; MRI, magnetic resonance imaging.