Coprimary and secondary efficacy end points
| Variable | Month 1 | Month 3 | Month 12 | |||
| MSCs (n=30)* | MSCs+IFN-γ (n=30)* | MSCs (n=30) | MSCs+IFN-γ (n=30) | MSCs (n=30) | MSCs+IFN-γ (n=30) | |
| Efficacy (Good or Moderate EULAR response)—% of patients (SD) | 23.3 (42.3) | 86.7 (34.0)† | 53.3 (49.9) | 93.3 (24.9)† | 50.0 (50.0) | 93.3 (24.9)† |
| DAS28-ESR <2.6—% of patients (SD) | 0.0 (0.0) | 3.3 (18.0) | 3.3 (18.0) | 10.0 (30.0) | 3.3 (18.0) | 13.3 (34.0) |
| DAS28-ESR ≤3.2—% of patients (SD) | 0.0 (0.0) | 33.3 (47.1)† | 16.7 (37.3) | 40.0 (49.0) | 10.0 (30.0) | 36.7 (48.2)† |
| ACR 20 response—% of patients (SD) | 23.3 (42.3) | 86.7 (34.0)† | 53.3 (49.9) | 93.3 (24.9)† | 50.0 (50.0) | 93.3 (24.9)† |
| ACR 50 response—% of patients (SD) | 6.7 (24.9) | 33.3 (47.1)† | 20.0 (40.0) | 36.7 (48.2) | 20.0 (40.0) | 36.7 (48.2) |
| ACR 70 response—% of patients (SD) | 3.3 (18.0) | 10.0 (30.0) | 3.3 (18.0) | 13.3 (34.0) | 3.3 (18.0) | 13.3 (34.0) |
| △DAS28-ESR (SD) | −0.69 (0.64) | −2.14 (0.60)† | −1.05 (0.95) | −2.51 (0.58)† | −1.28 (1.03) | −2.54 (0.60)† |
| △HAQ-DI (SD) | −0.17 (0.29) | −0.59 (0.28)† | −0.37 (0.24) | −0.73 (0.24)† | −0.40 (0.26) | −0.87 (0.27)† |
*Only data from patients who completed 48 weeks of follow-up were included here.
†P<0.05 for the comparison with MSCs.
ACR, American College of Rheumatology; DAS28-ESR, Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate; EULAR, European League against Rheumatism; HAQ-DI, Health Assessment Questionnaire-Disability Index; IFN-γ, interferon-γ; MSCs, mesenchymal stem cell; SEM, SE of mean.