Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV*) *MSV: Mesenchymal Stromal Cells From Valladolid
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). We propose here a multicenter, phase I-II clinical trial, prospective, randomized, blinded, and controlled for the treatment of osteoarthritis (degrees II and III and IV). The assay consists of two arms with 15 patients each one. Patients in the experimental arm will be given an intra-articular transplantation of allogenic MSC, expanded "Ex Vivo" with our GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as in NCT01183728). In the control arm a standard treatment with intra-articular injection of hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality of life and quantitative changes in structure and composition of cartilage determined by T2-weighted MRI relaxation (Cartigram) for one year.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee osteoarthritis grade II, III and IV of Kellgren and Lawrence assessed by two observers.
- •Chronic knee pain with mechanical characteristics.
- •No local or systemic septic process.
- •Haematological and biochemical analysis without significant alterations that contraindicate treatment.
- •Informed written consent of the patient.
- •The patient is able to understand the nature of the study
排除标准
- •Age over 75 or under 18 years or legally dependent
- •Present Infection (to be included in the study no signs of infection must be evidenced)
- •Congenital or acquired malformation resulting in significant deformity of the knee (varus<10º; valgus<20º) and leading to problems in application or evaluation of results.
- •Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
- •Women who are pregnant or intend to become pregnant or breast-feeding
- •Neoplasia
- •Immunosuppressive states
- •Intra-articular infiltartion of any treatments in the last 3 months previous to study inclusion
- •Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
- •Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
研究组 & 干预措施
Allogenic mesenchymal stromal cells injection
Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.
干预措施: Allogenic mesenchymal stromal cells injection (Other)
Hyaluronic acid (Durolane)
Intraarticular injection of hyaluronic acid (60 mg)
干预措施: Hyaluronic Acid (Drug)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
时间窗: Up to one year
Adverse events reported. Clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months
次要结局
- Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)(up to one year)
- Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)(up to one year)