Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee: Effect on Pain and Quality of Life
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- OhioHealth
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score
研究概览
简要总结
The purpose of this study is to determine the clinical response to autologous bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP) injections for knee osteoarthritis with respect to pain, function, and quality of life at up to 1 year following the intervention. Specifically, the clinical response will be compared to baseline and a control group treated with a Gel-One® hyaluronate injection to the target knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients 40 to 70 years old
- •Diagnosed with knee osteoarthritis based on the American College of Rheumatology criteria including symptomatic reports and radiographic findings
- •Kellgren-Lawrence grade 1-3 based on a radiograph within 6 months of presentation to the clinic
- •Symptomatic evidence of tibiofemoral osteoarthritis for ≥6 months
- •Average numeric pain rating of 4 - 8 on a scale of zero to 10 (defined as moderate level) over the past week
- •Previous trial of 6 weeks minimum of conservative therapy including physical therapy, weight loss, anti-inflammatory medication, or injection therapy
排除标准
- •Grade 4 knee osteoarthritis according to the Kellgren-Lawrence scale
- •History of intraarticular viscosupplementation or steroid injection in the target knee in the past 6 months at the time of the baseline visit or intraarticular injection planned during the trial
- •History of arthroscopic surgery in the target knee in the past 12 months at the time of presentation to the clinic or planned surgery during the trial period (e.g., scheduled for/awaiting arthroscopy or a knee replacement procedure)
- •Bilateral knee osteoarthritis (unless the contralateral knee involvement is limited to radiographic osteoarthritis and not symptomatic)
- •Ipsilateral (same side) or contralateral (opposite side) symptomatic osteoarthritis of hip or ankle
- •Clinically apparent tense effusion or other acute inflammation of the target knee at the time of presentation to the clinic
- •Active infection of either lower extremity such as cellulitis or any skin disease or infection in the area where BMAC is aspirated, blood is drawn, or an injection is given
- •History of diagnosis of any of the following: 1) septic osteoarthritis of any joint, 2) inflammatory arthropathy such as rheumatoid arthritis, gout, pseudogout, lupus, crystalline arthropathy, chondrocalcinosis and other rheumatology diagnoses
- •Cruciate/collateral knee ligament instability, ligament laxity, or meniscal instability of the target knee
- •Significant alignment deformity such as varus/valgus of the target knee in the judgment of the investigator
- •Currently pregnant, nursing, or planning to become pregnant during the trial period
- •Previous or known allergic reaction or hypersensitivity to heparin; sodium citrate; hyaluronan products or specifically Gel-One®; cinnamon; bird products such as feathers, eggs, or poultry; avian proteins
- •Not suitable for BMAC tissue allograft injection per physician (e.g., blood dyscrasia)
- •Unable to be prescribed stable dose of NSAIDs and/or tramadol based on medical history as ad lib use of over-the-counter analgesics will be allowed in both groups after treatment
- •Current cigarette smoker
- •Unable to give informed consent
- •Non-English speaking
研究组 & 干预措施
BMAC injection and PRP injection
Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.
干预措施: BMAC injection (Biological)
BMAC injection and PRP injection
Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.
干预措施: PRP injection (Biological)
Gel-One® hyaluronate injection
Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).
干预措施: Gel-One® hyaluronate injection (Device)
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score
时间窗: Change from baseline to 3, 6, and 12 months post-treatment
Subscales include pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life. Each subscale is 0-100 with 100 indicating the best possible score.
次要结局
- Numeric Pain Rating Scale(Change from baseline to 3, 6, and 12 months post-treatment)
- Patient Reported Outcome Measurement Information System Global Health Scores(Change from baseline to 3, 6, and 12 months post-treatment)
研究者
Joseph Ruane
Principal Investigator - Medical Director, McConnell Heart Health Center
OhioHealth