BackgroundOsteoporosis (OP) is a systemic bone disease characterised by decreased bone mass and deterioration of bone microarchitecture with increased brittleness and fracture risk. It associates high morbidity and mortality for patients and has a high impact on health expenditure. Bone marrow stromal mesenchymal stem cells (BM-MSC) give rise to osteoprogenitor cells and osteoblasts and influence bone homeostasis. However after their intravenous (i/v) infusion their osteotropism is limited. Our group has demonstrated that the exofucosylation of the CD44 membrane antigen in MSC improves their homing to bone tissue and that the infusion of these cells is safe in a murine model.ObjectivesTo evaluate the safety of i/v infusion of fucosylated BM-MSC in patients with OP, and secondarily assess their ability to improve the course of the diseaseMethods10 women between 50 and 75 years old diagnosed with osteoporosis with a low impact fracture will be included and treated i/v with autologous fucosylated BM-MSC. The first 4 patients were treated with a dose of 2 × 106 cells/kg body weight and the other 6 with 5 × 106 cells/kg body weight. A 24 month follow-up will be conducted to evaluate the rate of severe and non-serious adverse events and secondary endpoints (decreased fracture rate, pain scores, functional status and quality of life, biochemical indexes of bone metabolism, quantitative computed tomography for morphometric and mechanical analysis of bone quality, densitometry, and histomorphometryResultsSeven patients have been recruited to date. Two left the study for lack of cell proliferation and appearance of a complex form in karyotype during the cell culture, respectively. The first 4 patients were successfully infused, and after a median follow-up of 3 months no related adverse effects have been observed, no new osteoporotic fractures have appeared, and the analogue pain scale score (EVA) shows a tendency to decrease of pain in 3 of the 4 patients.ConclusionsOur preliminary data indicate that clinical and GMP-grade production of BM-MSC is feasible. We have not observed any short-term adverse effects associated with treatment in infused patients.Disclosure of InterestNone declared

BackgroundThe clinical coexistence of Systemic Lupus Erythematosus (SLE) and Sjögrens Syndrome (SS) was recognized in 1959. The prevalence of SS among patients with SLE varies considerably among the published studies (10%–30%). There is still controversy as to whether or not SLE patients with overlapping SS have a distinct and significantly milder lupus. To address the clinical and serologic features of SLE and differences from SLE that occurs in overlap with SS.MethodsThis is a multicenter, descriptive, cross-sectional study of 3575 patients from the Spanish Society for Rheumatology Lupus Registry (RELESSER). Unselected SLE patients from 45 Rheumatology Departments across Spain were evaluated for the presence of overlapping SS using the American-European consensus criteria. Cumulative clinical data were collected at the moment of the last assessment. Clinical and laboratory parameters in SLE patients with SS (SLEwSS) were compared with those in SLE patients without SS (SLEwoSS).ResultsSS was identified in 516 SLE patients (14.4%). Compared with the SLEwoSS group, patients with SLEwSS were significantly older, had a higher frequency of mucocutaneous manifestations, Raynauds phenomenon, peripheral neuropathy, anti-Ro/SSA, anti-La/SSB, neoplasia, and older age at death, but had a significantly lower frequency of renal involvement, thrombocytopenia, anti-dsDNA, anti-2-GPI IgM and complement consumption. Both groups displayed a clinically similar presentation of lymphadenopathy, systemic vasculitis, serositis, damage accrual, mortality, musculoskeletal and CNS manifestations.Abstract 121 Table 1ConclusionsSLEwSS appears to constitute a subgroup of SLE patients with distinct clinical and serologic features, in whom SS is expressed as an overlapping entity. A particular cluster of clinical variables, namely, mucocutaneous manifestations, Raynauds phenomenon, peripheral neuropathy, renal involvement and thrombocytopenia, was found to be important overall for discriminating SLE patients with or without SS. SLEwSS patients constitute a subgroup of patients with SLE characterized by milder lupus: older age at death, similar rates of mortality and SLICC-ACR damage index, less renal and immunological manifestations.Funding Source(s):None