Bone Marrow vs Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster University Osteoarthritis index (WOMAC) - Pain subscale
研究概览
简要总结
The MAST-GR study is a randomized controlled interventional trial with parallel treatment arms and 1:1 allocation
The primary objective of the study is to compare the safety and efficacy of a single intra-articular infiltration of Bone marrow aspirate concentrate (BMAC) with one of minimally manipulated adipose tissue (MM-AT) so as to determine the most effective cellular product in treating patients with knee osteoarthritis (OA).
The secondary objective is to demonstrate whether intra-articular infiltration of BMAC or MM-AT can induce disease-modifying effects in knee OA by imaging and biological assessments on peripheral blood.
The tertiary objective of the study is to identify factors that influence the clinical response to treatment (baseline characteristics of patients, biological characteristics of the treated knee, characteristics of cellular products, BMAC and MM-AT).
详细描述
Patients with symptomatic unilateral knee OA will be included in a randomized controlled Trial (RCT), in which one group of patients will be treated with 1 intra-articular infiltration of BMAC, and one group will be treated with 1 intra-articular infiltration of MM-AT. A total of 204 patients will be included and will undergo infiltrative treatment after collecting informed consent for study participation and master data. Patients will be clinically evaluated at 0-2-6-12 months follow-up. Possible disease-modifying effects of the two cell products will be investigated by analysis on peripheral blood at 0-2-6-12 months follow-up and by evaluation of radiographic and magnetic resonance imaging (MRI) at 0 and 12 months follow-up. In addition, characterization of the portion of BMAC and MM-AT remaining from treatment will be carried out, as well as baseline assessment of peripheral blood on all patients, and synovial fluid and synovial membrane, where possible, to analyze their influence on clinical outcome.
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)
盲法说明
To ensure the blinding of the health care personnel who will perform the checks (single-blind), follow-up visits will be performed by physicians not involved in the treatment procedures.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic unilateral knee OA with:
- •Men or women aged 40 to 75 years;
- •Signs and symptoms of OA with a clinical history of gonalgia or swelling for at least 6 months;
- •Radiographic signs of OA (Kellgren-Lawrence grade 1-4);
- •No benefit after at least 4 months of conservative treatment;
- •Ability and consent of patients to actively participate in clinical and radiological (rx and MRI) follow-up;
- •Signing of informed consent.
排除标准
- •Patients unable to express consent;
- •Patients aged < to 40 and > to 75 years;
- •Patients with axial deviations > 5°;
- •Patients who have suffered trauma or undergone intra-articular infiltration of other substance in the previous 6 months;
- •Patients who have undergone knee surgery in the previous 12 months;
- •Patients with concomitant knee injuries causing joint pain or swelling (-focal full-thickness osteochondral defects, acute meniscal injuries);
- •Patients with malignant neoplasms;
- •Patients with uncompensated systemic diseases (rheumatic diseases, metabolic disorders such as diabetes and thyroid diseases);
- •Patients with infectious diseases;
- •Patients with histories of alcohol or drug abuse;
- •Patients who are pregnant;
- •Patients with allergies to anesthetics used in the procedure.
研究组 & 干预措施
single intra-articular injection of BMAC
Patients randomized in this group will undergo single knee intra-articular injection of bone marrow aspirate concentrate (BMAC)
干预措施: Bone marrow aspirate concentrate injection (Biological)
single intra-articular injection of MM-AT
Patients randomized in this group will undergo single knee intra-articular injection of minimally manipulated adipose tissue (MM-AT)
干预措施: intra-articular injection of Minimally manipulated adipose tissue (Biological)
结局指标
主要结局
Western Ontario and McMaster University Osteoarthritis index (WOMAC) - Pain subscale
时间窗: 6 months follow-up
It is a pathology-specific questionnaire used for the assessment of referred pain at the knee joint level in patients with OA
次要结局
- Visual Analogue Scale (VAS)(baseline, 2 months, 6 months, 12 months follow-up)
- Objective parameters - Circumferences(baseline, 2 months, 6 months, 12 months follow-up)
- Minimally Clinical Important Difference (MCID)(baseline, 2 months, 6 months, 12 months follow-up)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(baseline, 2 months, 6 months, 12 months follow-up)
- EuroQol Visual Analogue Scale (EQ-VAS)(baseline, 2 months, 6 months, 12 months follow-up)
- Tegner Activity Level Scale(baseline, 2 months, 6 months, 12 months follow-up)
- Patient Acceptable Symptom State (PASS)(baseline, 2 months, 6 months, 12 months follow-up)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(baseline, 2 months, 6 months, 12 months follow-up)
- Objective parameters- Range of Motion(baseline, 2 months, 6 months, 12 months follow-up)
- Kellgren-Lawrence score(baseline, 12 months follow-up)
- Expectations about the effectiveness of the treatment(baseline)
- 3 Tesla Nuclear Magnetic Resonance Imaging (3T MRI)(baseline, 12 months follow-up)
- Analysis of circulating micro RNAs(baseline, 2 months, 6 months, 12 months follow-up)