Recovery of Joint Cartilage in Adults With Knee Osteoarthritis by Use of Mesenchymal Stromal Cells Derived From Human Umbilical Cord: Randomized Controlled Clinal Trial With Clinical and Radiologic Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 主要终点
- Changes in Visual Analogue scale (VAS)
研究概览
简要总结
The treatment of osteoarthritis (OA) of the knee remains still controversial. Despite that fact advanced stages with symptomatic and functional improvement are obtained with total knee replacement, however, there is no treatment that neither modifies the natural history of this disease, nor avoid joint replacement surgery in young patients in whom the prosthesis has conflictive indications. Moreover, prosthetic surgery leads to lower long-term survival and in older patients, higher morbidity and mortality. Cell therapy promises to be a treatment option through the use of mesenchymal cells with the capacity control inflammatory responses and trigger the differentiation into chondrocytes. Here we propose a randomized placebo-controlled clinical trial to evaluate radiologic and clinical outcomes in patients with knee OA.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain most days for the last month. Presence of osteophytes. Synovial fluid with mechanical characteristics. Morning stiffness for less than 30 minutes in the affected joint. Patellar crepitus. Patients aged 40 years or older and less than 60 years. Radiological criteria for osteoarthritis of the knee Kellgren-Lawrence 2 to 4 in comparative radiographs with knee support taken in the last 12 months prior to consultation.
- •Pain in one or both knees according to a visual analogue scale of 5 or more, out of 10 points in the last 3 months.
排除标准
- •Consumption of non-steroidal anti-inflammatory drugs or anticoagulants in the last 14 days.
- •Patient with a history of joint infiltration or arthroscopic surgery of the affected knee in the last 6 months.
- •Participants in another treatment or research study within the past year. Pregnant or lactating patients. Patient with active tumor pathology or a history of oncological disease. Patient with metabolic disease and/or uncontrolled coagulopathy at the assessment time.
- •Patients who have received previous treatments such as microfractures, and osteochondral allografts.
- •Patients with present meniscal lesions. Patients with a history of thyroiditis or thyroid nodules with increased antithyroglobulin antibodies.
- •Patients with a history of osteoarticular infection in the last 5 years or active at the time of assessment.
研究组 & 干预措施
IMUNOCEM
Administration of umbilical cord-derived mesenchymal stromal cells suspension
干预措施: INMUNOCEM (Biological)
PLASMALYTE
Administration of plasmalyte as vehicle for MSC
干预措施: PLACEBO COMPARATOR (Drug)
结局指标
主要结局
Changes in Visual Analogue scale (VAS)
时间窗: 30 months (day 0, day 1, month 1, month 3, month 6, year 1 and year 2
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between paints with similar conditions. Score ranges from 1 to 10, where 1 means lowest pain and 10 relates to highest pain
Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 30 months (day 0, month 3, month 6, year 1 and year 2)
KOOS reflects the individual disease burden and overall joint health. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale
Radiological changes in Magnetic resonance observation of cartilage repair tissue (MOCART 2.0)
时间窗: 30 Months (day 0, year 1 and year 2)
MOCART score was introduced based on 7 pertinent variables that facilitate a standardized, reproducible, semiquantitative approach for the morphological assessment of cartilage repair. Variables assesed in MOCART are: 1. Degree of cartilage defect; 2. integration into adjacent cartilage; 3. surface of the repair tissue; 4. structure of the repair tissue; 5. signal intensity of repaired tissue; 6. bony defect or bony overgrowth; 7. subchondral changes. The score ranges between 0 and 100, being 100 the maximum level of tissue compromise
次要结局
未报告次要终点
研究者
GUSTAVO SALGUERO
Research Leader Advanced Therapies Unit
Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS