Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis, A Randomized Placebo Controlled Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Subjects with Adverse Reactions to Concentrated Mesenchymal Stem Cells (MSCs)
研究概览
简要总结
The overall goal of this study is to develop regenerative cell therapy for use in patients with osteoarthritis (OA). The primary objective of this proposal is to conduct a pilot study that assesses the safety and feasibility of using concentrated bone marrow aspirate containing MSC to treat patients with painful knee OA.
详细描述
Patients with symptomatic mild to moderate bilateral knee osteoarthritis will be candidates for this pilot study. Baseline data includes radiographs, MRI imaging, clinical data on knee pain and analysis of synovial fluid inflammatory markers. Bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one knee will be injected with the bone marrow concentrate. The contralateral knee will be injected with only sterile saline for placebo. Follow-up analysis of synovial fluid will be at one week and 6 months after injection; clinical data will be obtained at 3, 6 and 12 months and MRI imaging will be performed at 6 months after injection, with repeat radiographs at 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female subjects are both eligible
- •Subjects must be 18 years of age or older
- •Subjects must have bilateral OA and pain in both knees.
- •Osteoarthritis may be primary or secondary. Knees must have Kellgren-Lawrence Grades 1-
- •Subjects must have previously tried 6 weeks of one of the following conservative treatments Activity modification, weight loss; physical therapy, anti-inflammatory or injection therapy
- •Patients can provide written informed consent after the nature of the study is fully explained
排除标准
- •Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results.
- •Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit.
- •Patients taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to study entry.
- •Patients receiving injections to the treated knee within 2 months prior to study entry.
- •Patients who are pregnant or currently breast-feeding children.
- •Patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis.
- •Patients with ongoing infectious disease, including HIV and hepatitis
- •Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
- •Patients participating in a study of an experimental drug or medical device within 30 days of study entry.
研究组 & 干预措施
Autologous bone marrow concentrate
Subjects with symptomatic mild to moderate bilateral knee osteoarthritis will be enrolled in this study. Bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one knee will be injected with the autologous bone marrow aspirate concentrate. The contralateral knee will be injected with only sterile saline for placebo.
干预措施: Autologous Bone Marrow Aspirate Concentrate (Drug)
Placebo
Subjects with symptomatic mild to moderate bilateral knee osteoarthritis will be enrolled in this study. Bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one knee will be injected with the bone marrow concentrate. The contralateral knee will be injected with only sterile saline for placebo.
干预措施: Sterile saline (Drug)
结局指标
主要结局
Number of Subjects with Adverse Reactions to Concentrated Mesenchymal Stem Cells (MSCs)
时间窗: 1 year
Occurrence of adverse reactions to concentrated MSCs from bone marrow aspiration injected into knee joints.
次要结局
- Mean Knee Cartilage(baseline, 6 months, 1 year)
研究者
Shane A. Shapiro
Orthopedic Consultant
Mayo Clinic