Articular Cartilage Regeneration in Gonarthrosis Grade II and III by Articular Infiltration of Xcel-m-condro-alpha.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration.
研究概览
简要总结
This is a prospective, open-label, single-dose, single-arm phase I-II study in which 15 patients diagnosed with gonarthrosis grade II-III (Kellgren and Lawrence) will enter the study with the primary objective of assessing the feasibility and safety of the knee articular infiltration of autologous bone marrow mesenchymal stem cells (MSC). Secondary objectives are to assess the efficacy by imaging procedures and clinical questionnaires.
MSC obtained from each patient's bone marrow will be isolated and expanded "Ex-Vivo" under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, patients will be implanted a single-dose of approximately 40 millions of autologous MSC in the knee by articular injection, and followed up for 12 month. Articular cartilage changes will be determined by T2-weighted MRI (Cartigram) at 6 and 12 month. Clinical assessment will measure the pain by the visual analogue scale (VAS), the self-reported functional status by Heath Assessment Questionnaire (HAQ), and the quality of life by Short Form 36 questionnaire (SF-36) at 3, 6 and 12 month.
The working hypothesis proposes that the expected regenerative articular cartilage effect of the MSC will be produced to a measurable degree by imaging procedures and clinical questionnaires.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gonarthrosis grade II-III of Kellgren and Lawrence assessed by two observers
- •Chronic knee pain with mechanical characteristics
- •Absence of local or systemic septic process
- •Haematological and biochemical laboratory tests without significant alterations that contraindicate treatment.
- •Informed Consent form signed by the patient
- •The patient is able to understand the nature of the study
排除标准
- •Patients < 18 years or legally dependent
- •Patients >65 years
- •Previous surgery of the knee
- •Intraarticular treatment in the past 6 month
- •Knee ligament or meniscus rupture observed by MRI
- •Any sign of infection
- •Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) and syphilis.
- •Congenital or acquired malformation resulting in significant deformity of the knee 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).
- •Pregnant women or intend to become pregnant or breast-feeding
- •Immunosuppressive states
- •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
结局指标
主要结局
Safety of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration.
时间窗: 12 months
Safety will be assessed by collecting adverse events throughout the experimental phase, including the follow-up at 12 months.
Feasibility of autologous bone marrow mesenchymal stem cells (MSC) knee articular infiltration.
时间窗: 12 months
Feasibility will be assessed by checking the cascade of procedures (from bone marrow extraction to MSC implantation) and confirming the global process is viable.
次要结局
- Efficacy by imaging procedures.(12 month)
- Clinical outcomes.(12 months)