[unknown title]

Mesenchymal stem cells (MSCs) are multipotential nonhematopoietic progenitors and are capable of differentiating into several tissues of mesenchymal origin. We have shown that bone marrow derived MSCs from both SLE patients and lupus prone MRL/lpr mice are defective structurally and functionally. Here we observe the long-term safety and efficacy of allogeneic MSC transplantation (MSCT) in treatment-resistant SLE patients. Eighty-seven patients with persistently active SLE who were refractory to standard treatment or had life-threatening visceral involvement were enrolled. Allogeneic bone marrow or umbilical cord derived MSCs were harvested and infused intravenously (1?10? cells/kg of body weight). Primary outcomes were rates of survival, disease remission and relapse, as well as transplantation related adverse events. Secondary outcomes included SLE disease activity index (SLEDAI) and serologic features. During the 4 years follow up and with a mean follow up period of 27 months, the overall rate of survival was 94% (82/87). Complete clinical remission rate was 28% at 1 year (23/83), 31% at 2 years (12/39), 42% at 3 years (5/12) and 50% at 4 years (3/6). Rates of relapse were 12% (10/83) at 1 year, 18% (7/39) at 2 years, 17% (2/12) at 3 years and 17% (1/6) at 4 years. The overall rate of relapse was 23% (20/87). Disease activity declined as revealed by significant changes in SLEDAI score, levels of serum autoantibodies, albuminand complements. A total of 5 patients (6%) died after MSCT from non-treatment-related events in 4 years follow up, and no transplantation-related adverse event was observed. Allogeneic MSCT resulted in the induction of clinical remission and improvement in organ dysfunction in drug-resistant SLE patients. No transplantation-related adverse event was observed.