| Background:Ankylosing spondylitis is one type of autoimmune diseases, charactered as chronic progressive sacroiliac arthritis,peripheral inflammatory joint disease and axial spondylorathitis.Besides joints, eye, lung, cardiovascular, kidney, nervous system and other organs could also be affacetd or damaged by the chronic inflammation. Disorders of T and B cells are implicated in the pathogenesis of AS. Low back pain and joint activity limitations are the most frequently observed symptoms of the disease. Diagnosis of the AS mainly depends on the modified New York criteria (1984). At present, treatment depends on drugs, including non-steroidal anti-imflammatroy drugs, salazosulfa pyridine, glucocorticoid, tumor necrosis factor inhibitors.Objective:To evaluate safety and efficacy of mesenchymal stem cells infusion in the treatment of ankylosing spondylitis.Materials and methods:1. Materials:Five cases of ankylosing spondylitis patients which met diagnostic criteria of ankylosing spondylitis(the modified New York criteria (1984) for AS). Their age were between 18 and 60-year-old. if they took non-steroidal anti-inflammatory drugs (NSAID), methotrexate (MTX), salazosulfadimidine (SSZ),hydroxychloroquine, low dose steroid,the dose of the drugs had been stable for 4 weeks, before they joined in the study. The patients in poorly controlled medical condition, such as suffered from organ failure, psychosis, severe pulmonary artery hypertension, and heart association functional classification III or IV according to New York Heart. Association functional classification were excluded. Therefore, patients enrolled the study, were without severe infectious disease, such as tuberculosis (TB), AIDS, hepatitis..The female patients was not pregnant or during lactate stage. The patients enrolled any other biological or investigational biological agent in the past 4 weeks, were excluded. Patients allergic to MSC or preserving fluid were out of the study.The assessment were made, including:physical examination, BASDAI, BASFI, BASDI, erythrocyte sedimentation rate(ESR), C-reactive protein(CRP), blood routine, urine routine,liver function, kidney function and imaging detection.2. Methods:Five patients with AS were recruited from the second hospital of Shandong University in China. MSCs (uMSCs) were isolated from umbilical cord tissue and expanded. All the adverse and treatment response were investigated and recorded during the observation time of the uMSC treatment. This study was approved by the Ethical Committee of the Second Hospital of Shandong University.The patients were given the infusion of MSC, with the dose of 1IU/Kg(1IU=1×107 MSCs), for 1 or 2 times. Adverse effects, physical examination, BASDAI, BASFI, BASDI, laboratory parameters(erythrocyte sedimentation rate(ESR), C-reactive protein(CRP), blood routine, urine routine, liver function and kidney function), and imaging examinations were recorded or performed to determine adverse effects and treatment efficacy of MSCs before and after MSCs administration intravenously.Result:1. The three out of five had a fever after the infusion of MSC, with the temperature ranging from 38.5 to 39℃. When the temperature reached to or over 39℃,dexamethasone(DEX) or NSAIDs was given to relieve fever and temperature of the patients returned to the normal range within 2-6 hours.2. The comparison between prior to treatment and post treatment: the score of BASDAI and BASMI both decreased, and the score of BASFI increased. The level of ESR and CRP were reduced. Meanwhile the symptoms of AS alleviated.Conclusion:Our results here showed that intravenous transfusion of uMSC is safe and well tolerated, and effectively alleviated the disease activity and clinical symptoms. The findings obtained from this study supports a future study in a large cohort of AS patients in order to systemically evaluate therapeutic effects of uMSCs on AS. |
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