RBR-7qjcdd招募中3 期
Randomized, controlled, open and parellel trial to evaluate the efficiency and safety of intra-articular infiltration of Autologous Bone Marrow Concentrate (BMC) or Mesenchymal Stem Cell (MSC) associated with Platelet Rich Plasma (PRP) in patients with primary knee osteoarthritis - START: START
Prevent Senior Private Operadora de Saúde LTDA0 个研究点开始时间: 2019年6月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 49Y 至 75Y（—）
入选标准
- •Adults with age in between 49 and 75 years old; Clinical and radiological diagnosis of primary knee osteoarthritis with lesion of mild to moderate intensity (II and III) based on the classification criteria of the American
- •College of Rheumatology (Altman et al., 1986) with radiological confirmation following a Kellgren and Laurence scale (1957); History of knee edema, pain, stiffness, gait alteration and loss of movement due to the degenerative joint process; Availability of follow-up during the study period; Have provided written voluntary consent to participate in the study, confirmed by the signature of Informed Consent Form.
排除标准
- •BMI greater than or equal to 35; Being a carrier of other joint diseases or joint trauma, autoimmune diseases or have been subjected to the use of disease modifying drugs or intra-articular medication in the last 6 months; Evidence of secondary osteoarthrosis or with a history of other diseases in the articulation study, such as fractures, neoplasms, primary hematological disease, autoimmune, rheumatologic, neurological disease; History of acute or chronic communicable diseases, including B hepatitis; History of bone or cartilaginous disorders; Diagnosis of type I or type II diabetes, poorly controlled; Diagnosis of Hip Arthrosis through alteration in the physical examination or report with radiographic changes in the hip of the same side or contralateral; Evidence of active infection or history of infection in the joint to be infiltrated in this study; Any disease that affects the contralateral lower limb, such as consequence of OA of the knee; Deviation of the axial axis varus of 10 degrees or 15 degrees in valgus or discrepancy greater than 2.5 cm diagnosed by panoramic radiographic examination of limbs lower; Comorbidity that the physician considers as a contraindication for the infiltration of autologous stem cells; Contraindication to aspiration of the bone marrow (severe coagulopathy, skin infection in the area of ??the posterior iliac crest); Chronic treatment with anticoagulant or immunosuppressive drugs, except AAS 100mg; Use of a systemic corticosteroid in the last 3 months; Use of nonsteroidal anti-inflammatory drug in the last 15 days; Change in the use of oral chondroprotection continued for less than 3 months; Previous surgery (at any time) of the affected knee or orthopedic surgery lower limbs in the last 12 months; Present renal and / or hepatic functions out of normality; Present values ??that are not normal in laboratory tests, according to reference values; Hypersensitivity to any investigational product; Other clinical conditions which may, according to medical criteria, discourage participation in the study; Pregnant or otherwise pregnant women who do not use methods contraceptives; Development of clinical conditions that compromise the response to questionnaire and that may influence the results of the study.
研究者
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