Session Title: Systemic Lupus Erythematosus: Clinical Aspects
Session Type: Abstract Submissions (ACR)
Background/Purpose: Umbilical cord (UC) derived mesenchymal stem cells (MSCs) have shown safety profile and therapeutic effect in severe and refractory systemic lupus erythematosus (SLE) in our single-centre pilot study. The present multicentre clinical trial was undertaken in China to assess the efficacy and safety of allogenic UC MSCs transplantation (MSCT) in active SLE patients.
Methods: Forty patients (aged ≥16 years) with active SLE (SLE Disease Activity Index >6) were enrolled from 4 clinical centres in China. All patients gave informed consents before transplantation, and allogenic UC MSCs were infused intravenously on days 0 and 7. Adverse event was monitored during and after MSCs transplantation. Primary efficacy endpoints were major clinical response (MCR), partial clinical response (PCR) and relapse at 6 and 12 months. Secondary endpoints were improvement in SLEDAI score, British Isles Lupus Assessment Group (BILAG) score, serum levels of creatinine, urea nitrogen, complements and albumin pre- and post-MSCT.
Results: Fourteen and fifteen patients achieved MCR (14/40, 35.0%) and PCR (15/40, 37.5%) at 6 months follow-up, respectively. Three and four patients experienced disease relapse at 9 (7.5%) and 12 (10%) months follow-up, respectively, after a prior clinical response. SLEDAI score significantly decreased at 3 (7.43±3.93), 6 (6.30±3.63), 9 (6.40±3.84) and 12 months (6.48±3.52) follow-up (P all <0.05 vs. baseline 10.83±4.63). Total BILAG score markedly decreased 3 months after MSCT, and continued to decrease in the following visit times. BILAG score for renal and hematopoietic system significantly improved. For those with lupus nephritis, 24-hour proteinuria declined after transplantation, with statistical differences at 9 (1.24±1.09 mg) and 12 months (1.41±1.33 mg, P<0.05 vs. baseline 2.24±1.43 mg). Serum creatinine and urea nitrogen decreased to the lowest level at 6 months, while slightly increased at 9 and 12 months due to the 7 relapsed cases. Additionally, Serum levels of albumin, complements 3 and 4 increased after MSCT, peaked at 6 months visit, then slight declined at 9 and 12 months. Serum anti-nuclear antibody (ANA) and anti-double strand DNA (dsDNA) antibody decreased after MSCT, with statistical differences at 3 months follow-up. Furthermore, hemoglobin and platelet counts increased after MSCT in those with hematopoietic involvement. UC-MSCT was well tolerated and no adverse event was observed.
Conclusion: Our findings indicate that UC MSCT results in satisfactory clinical responses in SLE. However, several cases experienced disease relapse after 6 months visit, which suggests the necessity for repeated MSCT after 6 months in some patients.
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