Assessment of the Functional, Clinical and Radiological Efficacy of Stromal Vascular Fraction Treatment for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change from baseline knee pain measured with a Visual Analogue Scale (VAS) at 1 year
研究概览
简要总结
One-year follow-up prospective observational study involving male and female patients (over 18-years-old) with unilateral or bilateral knee osteoarthritis treated with intraarticular injection of stromal vascular fraction (SVF) treatment. Clinical, biological and radiological data before the treatment and 1-month, 6-month and a year after are collected.
The research hypothesis supports that SVF treatment enhance functionality and quality of live, relieves pain and improves magnetic resonance images of joint cartilage in patients with knee osteoarthritis.
详细描述
The research consists on one-year follow-up prospective observational study. It involves male and female patients (over 18-years-old) with unilateral or bilateral knee osteoarthritis treated with intraarticular injection of stromal vascular fraction (SVF) treatment developed by Cellab Laboratory (Celstem®).
The aim of the study is to assess pain efficacy with SVF treatment for knee osteoarthritis patients. To assess pain, Visual Analogue Scale (VAS) is used.
Secondarily, the study aims to determine the differences pre-post treatment with SVF of the secondary outcomes measures: functionality, quality of life and disability. Is is used KOOS scale, Short Form-36 questionnaire (SF-36) and World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) to assess such measures, respectively. It also aims to describe and evaluate the regeneration of joint cartilage of each individual by systematic comparison of magnetic resonance imaging (MRI) before and one year after SVF treatment, measured by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale. Moreover, specific sociodemographic and clinical factors that can predict or influence the therapeutic effects and its correlation to biological data (cellularity, immunophenotype, colony formation potency and sterility) will be identified. Adverse events or side effects related to the treatment will be reported.
Both primary and secondary outcome measures are evaluated prior to treatment, at 1-month, 6-months and one year after treatment except for the assessment of disability and the radiological features of the articular cartilage, which are performed only before and one year after. The radiological assessment according to MOCART classification is performed by a radiologist. This specialised physician is not aware of patients evolution in order to obtain minimize subjective bias. In addition, SVF product biological data, such as the amount of sample of extracted adipose tissue, effective dose, cellularity, immunophenotype, potency sample colonies and sterility, are collected to better describe the product and to be able to correlate the clinical effect with biological features.
The study was approved by the Clinical Research Ethics Committee of Nostra Senyora de Meritxell Hospital on September 20th, 2018. It is expected to last 4 years, from 2018 to 2022.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female over 18 years of age patients affected from unilateral or bilateral symptomatic knee osteoarthritis (KOA), determined by the diagnostic criteria of the American College of Rheumatology. Any degree of the Kellgren and Lawrence classification for KOA is included. Patients included must have KOA symptoms more than 6 months. Symptomatology must remain despite having done conventional treatment for KOA.
排除标准
- •Suspicion, diagnosis or history of active or recent joint infection (less than 6 months)
- •Neurological deficit in the affected limb
- •Pregnant or breastfeeding women
- •Positive serology for hepatitis B, hepatitis C and / or HIV
- •Magnetic resonance imaging without pathological alterations
- •Knee infiltration with glucocorticoids, hyaluronic acid, platelet - rich plasma and / or other regenerative medicine therapies in the last 3 months.
- •Medical conditions, including the diagnosis of oncological pathology or infectious and severe heart, kidney or liver disease, which contraindicate sedation or liposuction procedure.
- •History or diagnosis of dementia or higher functions unpreserved, which interfere communication.
- •Not having the necessary skills and / or electronic devices necessary (even their relatives or acquaintances, or they can not help them) to complete the online questionnaires.
结局指标
主要结局
Change from baseline knee pain measured with a Visual Analogue Scale (VAS) at 1 year
时间窗: Pain is assessed pre-intervention and at one year of follow-up.
Joint pain measured using the Visual Analogue Scale (VAS), which allows the patient to score from 0 to 10, 0 being that there is no pain, and 10 the worst pain imaginable.
次要结局
- Change from baseline functionality measured with Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 year(Functionality is assessed pre-intervention and at one year of follow-up.)
- Change from baseline quality of life measured with SF-36 questionnaire at 1 year.(Quality of life is assessed pre-intervention and at one year of follow-up.)
- Change from baseline disability measured with WHODAS 2.0 questionnaire at 1 year.(Disability is assessed pre-intervention and at one year of follow-up.)
- Change from baseline joint cartilage characteristics measured with Magnetic Resonance Imaging at 1 year.(Joint cartilage characteristics are assessed pre-intervention and at one year of follow-up.)
研究者
Anna BOADA-PLADELLORENS
Principal Investigator
University of Andorra