Prediction AlgoriThm for regeneraTive Medicine Approach in knEe OA: New Decision-making Process Based on Patient pRofiliNg. (CO-2019-12370720 Prof. Kon BANDO DI RICERCA FINALIZZATA 2019)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- The mean KOOS score change from baseline to 12 months.
研究概览
简要总结
Osteoarthritis (OA) is a degenerative joint disease characterised by chronic pain, degradation and loss of articular cartilage, osteophyte formation and varying degrees of synovial inflammation.
Today, most of the available conservative treatments provide temporary relief of symptoms but have no effect on the cause and progression of the disease. Mesenchymal stem cells (MSC) have emerged as a durable and effective conservative treatment option for OA.
They are tissue cell-rich concentrates that have demonstrated immunomodulatory activities in several in vitro and in vivo studies, particularly in orthopaedics.
Thus, "minimal handling" methods for the intraoperative production of tissue cell-rich concentrates has become a widespread strategy in clinical practice. In particular, bone marrow aspirate concentrate (BMAC) and adipose tissue enriched SVF (at-SVF), i.e. the so-called 'orthobiologics', have proven to be cost-effective and promising sources with a high safety profile and positive short-term clinical results.
Despite growing evidence on the use of orthobiologics, the different methods of preparation and administration and the lack of meaningful data collection do not allow for a clear understanding of the true efficacy of these treatments, resulting in a lack of patient-specific indications.
Although the most common method of administering regenerative Although the most common method of administering regenerative medicinal products is by intra-articular injection, more recently it has been shown that in patients with OA the subchondral bone also undergoes significant pathological changes. Given this evidence, intra-osseous (bone-cartilage interface) injections of biological products may represent a promising approach.
详细描述
Multicentre, open-label, randomised, four-arm clinical trial. Patients enrolled in this clinical trial will undergo scheduled surgery for the treatment of grade 2-3 OA KL. After enrolment, patients will be assigned to 4 treatment groups:
- intra-articular injection of BMAC, 2) intra-osseous and intra-articular injection of BMAC, 3) intra-articular injection of at-SVF, 4) intra-osseous and intra-articular injection of at-SVF. Medical history, clinical and radiological features, and serum samples will be collected for each patient at baseline, along with cell counts of each product injected.
The primary efficacy objective is the mean change from baseline to 12 months in the mean scores of the Pain and Symptoms in the Knee and Osteoarthritis Outcome Score (KOOS) subscales for each arm.
The KOOS subscale scores of pain and symptoms will be aggregated and averaged as the primary outcome.
Secondary objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Patients aged 18-75;
- •Patients affected by knee OA KL 2-3;
- •Patients understanding the nature of the study and providing their informed consent to participation;
- •Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol;
- •Body mass index (BMI) ≤ 40 kg/m2;
- •Ability to provide written informed consent and can understand and comply with the requirements of the study.
排除标准
- •A 4-arms randomized clinical trial in 240 patients affected by knee OA KL 2-
- •Treatment groups: 1) intra-articular injection of BMAC, 2) intra-osseous and intra-articular injection of BMAC, 3) intra-articular injection of adipose tissue enriched in SVF (at-SVF) , 4) intraosseous and intra-articular injection of at-SVF.
- •Inclusion criteria:
- •Patients aged 18-75;
- •Patients affected by knee OA KL 2-3;
- •Patients understanding the nature of the study and providing their informed consent to participation;
- •Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol;
- •Body mass index (BMI) ≤ 40 kg/m2;
- •Ability to provide written informed consent and can understand and comply with the requirements of the study.
- •Exclusion criteria:
- •Patients with known inflammatory diseases at the time of enrolment.
- •Patients who are not allowed to undergo the study procedures involving imaging (X-rays, MRI) based on Investigator's judgement.
- •A history of local anaesthetic and anticoagulant drug allergy;
- •Clinically observed active infection in the index knee joint or skin disease/breakdown or infection in the area of the planned injection site of the index knee;
- •Major surgery (e.g. osteotomy) of the index knee within 12 months prior to screening;
- •Minor surgery (e.g. shaving or arthroscopy) of the index knee within 6 months prior to screening;
- •Patients who received intra-articular injection of corticosteroids, PRP or HA within the previous 3 months;
- •Use of systemic immunosuppressants within 6 weeks prior to screening;
- •Patients with a history of invasive malignancies (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years;
- •Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
- •Women who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical investigation and for three months later.
结局指标
主要结局
The mean KOOS score change from baseline to 12 months.
时间窗: 12 months
KOOS, IKDC and VAS questionnaires will be administered during screening visit and follow-up visits in order to monitor the evolution of the patients. KOOS subscales scores of Pain and Symptoms will be aggregated and averaged as primary outcome.
次要结局
未报告次要终点