Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Patients with at least one severe adverse event
研究概览
简要总结
The purpose of this study is to investigate the safety and effectiveness of bone marrow aspirate concentrate (BMAC) in patients with moderate to severe osteoarthritis of the knee. BMAC provides a rich source of mesenchymal stem cells (MSCs) and is a stem cell-based therapy that has been reported to preserve or improve the structure of joints. The Angel System is the device used in this study to concentrate bone marrow from the patient and is intended to separate a mixture of blood and bone marrow and collect plasma rich platelets preoperative to a surgical procedure. The goal of this study is to identify whether BMAC can be an effective and safe treatment for patients with osteoarthritis of the knee.
详细描述
This is a pilot open-label, non-randomized, single institution study of BMAC administration in patient's with moderate to severe osteoarthritis of the knee who will undergo total knee replacement. Several weeks prior to total knee replacement, patients will have a sample of bone marrow taken from their pelvic region and concentrated using an investigational device called the Arthrex Angel Concentrated Platelet Rich Plasma (cPRP) System also known as the Angel System. The concentrated bone marrow will be immediately delivered back to the patient arthroscopically to the knee of interest. Blood and tissues samples will be collected at scheduled visits for molecular and histological analysis. Adverse events will be monitored throughout the trial. Assessment of healing will be performed by physical exam and standardized questionnaires related to the health of the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kellgren Lawrence radiographic grade IV
- •Need for a total knee arthroscopy by the patients primary care provider/or orthopedist.
- •Persistent pain in target knee that is unresponsive to standard of care including acetametaphine, non-steroidal anti-inflammatory drugs, physical therapy and/or intraarticular corticosteroids and/or hyaluronic acid preparations.
- •Males or females aged 45-75.
排除标准
- 未提供
研究组 & 干预措施
Bone marrow aspiration concentrate using the Angel System
Bone marrow aspirate concentrate (BMAC) will be administered via injection to the knee of interest on day 14 of the study.
Bone marrow aspiration will be concentrated using the Angel System.
干预措施: Bone Marrow Aspirate Concentrate (Biological)
Bone marrow aspiration concentrate using the Angel System
Bone marrow aspirate concentrate (BMAC) will be administered via injection to the knee of interest on day 14 of the study.
Bone marrow aspiration will be concentrated using the Angel System.
干预措施: Angel Concentrated Platelet Rich Plasma (cPRP) System (Device)
结局指标
主要结局
Patients with at least one severe adverse event
时间窗: End of Study (12 months)
The number of life-threatening severe adverse events as determined by the standard FDA guidelines for adverse events that are deemed to be related to autologous BMAC concentrated by the Angel System and delivered via intra-articular injection into the knee.
次要结局
- Structural change in knee from baseline measured by the VAS (Visual Analog Scale) in the American College of Rheumatology/Knee Osteoarthritis Assessment Scale (ACR/KOAS).(End of study (12 months))
- Self reported health from baseline through end of study measured by the 36-Item Short Form Survey Instrument (SF-36) Health Survey and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).(End of study (12 months))
研究者
Kenneth Kalunian
Professor of Medicine
University of California, San Diego