A Phase I/II, Randomized, Controlled, Double Blind, Study of Chondrogen - Adult Universal Cell Delivered by Intra-Articular Injection Following Meniscectomy in Patients 18-60 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Meniscal Volume
研究概览
简要总结
The purpose of this study is to determine whether Chondrogen is a safe and effective post-operative treatment of the knee following menisectomy (the surgical removal of all or part of a torn meniscus).
详细描述
Chondrogen is a preparation of adult mesenchymal stem cells (MSCs) in a solution containing hyaluronic acid. Preclinical studies have shown that injection of Chondrogen aids in the repair of meniscal tissue following meniscectomy. In Chondrogen treated subjects, surgically removed meniscal tissue was regenerated, cartilage surface was protected, and joint damage was decreased in comparison to control subjects. These benefits persisted at least one year.
Three groups of recent meniscectomy patients will be followed in this study, including patients that will receive placebo and patients that will be treated with one of two possible doses of Chondrogen.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 60, inclusive
- •In need of medial meniscectomy
- •Normal axial alignment
- •Stable knee- previous ligament reconstruction, if stable
- •Removal of at least 50% of the affected portion of the medial meniscus
- •Intact articular cartilage in posterior meniscal weight-bearing zone
- •Willingness to follow normal post-operative rehabilitation
- •Willingness to participate in follow-up for two years from the time of meniscectomy surgery
- •Ability to understand and willingness to sign consent form
排除标准
- •Pregnant or lactating
- •ACL or other support structure damage confirmed at surgery
- •Grade III or IV cartilage damage (Cartilage loss greater than 50% thickness in area >15mm on weight-bearing aspect of femoral condyle or tibial plateau)
- •Synvisc, steroid, or corticosteroid injections in preceding 3 months
- •Diffuse synovitis at time of arthroscopy
- •Inflammatory arthritis
- •Oral steroid, methotrexate therapy
- •Unable to follow post-operative exercise regimen or return for evaluations
- •Active alcohol or substance abuse within 6 months of study entry
- •Current and active tobacco product use
- •Patient is positive for HIV
- •Patient is positive for hepatitis (past history of Hepatitis A is allowed)
- •Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
- •Indwelling pacemaker
- •Cerebral aneurysm clips
- •Ear, eye and penile implants with avian components
- •Electrical indwelling device such as bone stimulator
- •Indwelling magnets as tissue expander for future implants
- •Known allergy to avian, bovine or porcine protein
研究组 & 干预措施
Vehicle Control
Vehicle Control
干预措施: Hyaluronan (Drug)
Chondrogen - dose 2
Chondrogen - 150 million cells
干预措施: Mesenchymal Stem Cells (Drug)
Chondrogen - dose 1
Chondrogen - 50 million cells
干预措施: Mesenchymal Stem Cells (Drug)
结局指标
主要结局
Meniscal Volume
时间窗: 6 months
Changes in meniscal volume over the course of the study as determined by MRI
次要结局
- Lysholm Knee Scale(2 years)
- Safety Assessment Adverse Event(2 years)
- Safety Assessment Immunological(2 years)
- Safety Assessment Laboratory(2 years)
- Quality of Life Questionnaire(2 years)
- Visual Analog Scale (VAS)(Baseline to 2 years)
- Safety Assessment Physical Exam(2 years)
- Safety Assessment Magnetic Resonance Imaging (MRI)(2 years)