Primary and secondary endpoints
| Parameter | Placebo (n=6) | hUC-MSC (n=12) |
| Overall response to treatment | ||
| Remission of nephritis (combined partial and complete remission), no (%) | 5 (83) | 9 (75) |
| Complete remission of nephritis, no (%) | 3 (50) | 5 (42) |
| Mean time to remission, weeks (SD) | 7 (5) | 7 (4) |
| Renal disease activity | ||
| Mean 24 hours urine protein at 6 months, g/24 h (SD) | 3.1 (2.7) | 1.0 (1.0) |
| Mean change in 24 hours urine protein, g/24 h (SD)* | −1.4 (1.1) | −2.1 (1.8) |
| Mean serum albumin at 6 months, g/L (SD) | 36 (7) | 39 (5) |
| Mean change in serum albumin, g/L (SD)* | 9 (6) | 14 (6) |
| Mean serum creatinine at 6 months, µmol/L (SD) | 59 (9) | 63 (18) |
| Mean change in serum creatinine at 6 months, µmol/L (SD)* | −19 (25) | −7 (16) |
| Mean creatinine clearance at 6 months, mL/min (SD) | 118 (21) | 115 (32) |
| Mean change in creatinine clearance at 6 months, mL/min (SD)* | 27 (28) | 10 (21) |
| Renal impairment (creatinine clearance <60 mL/min) at 6 months, no (%) | 0 (0) | 0 (0) |
| SLE disease activity | ||
| Mean change in SLEDAI score (SD)* | −5 (8) | −8 (4) |
| SLEDAI score >8 at 6 months, no (%) | 4 (67) | 3 (25) |
| BILAG score A or B at 6 months, no (%) | 5 (83) | 8 (67) |
| Anti-dsDNA antibody raised (≥1:10) at 6 months, no (%) | 3 (50) | 1 (8) |
| ANA ≥1:80 at 6 months, no (%) | 5 (83) | 7 (58) |
| Mean change in ANA titre, unit (SD)* | −413 (732) | −248 (360) |
| Mean change in C3, mg/dL (SD) * | 33 (32) | 36 (35) |
| Mean change in C4, mg/dL (SD)* | 7 (8) | 11 (12) |
| Patient outcome | ||
| Death, no (%) | 0 (0.0) | 1 (8.3) |
| Permanent dialysis, no (%) | 0 (0.0) | 0 (0.0) |
*Change at 6 months from baseline value.
ANA, antinuclear antibody; BILAG, British Isles Lupus Assessment Group; dsDNA, double-stranded DNA; hUC-MSC, human umbilical cord-derived mesenchymal stem cell; SLE, systemic lupus erythematosus; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index.