Knee Osteoarthrosis (KOA) in Jordanian Patients: a Phase I Dose-finding Study Using Extracellular Vesicles (EV) for Advanced Stage III and IV KOA
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
Extracellular vesicles (EV) will be injected in patients diagnosed with Knee osteoarthrosis
详细描述
50 patients from both genders diagnosed with Knee osteoarthrosis, will be enrolled according to strict inclusion and exclusion criteria. These patients will be injected with Extracellular vesicles (EV). Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.
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
- 42 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe KOA stage III or IV by Laurance & Kellgren staging as judged by Posterioranterior (PA) Xray of the knee joint.
- •Willing to participate by signing the informed consent
排除标准
- •Sublaxation beyond 20 degrees of the bones of the knee joint
- •Oral anticoagulants or heparin therapy
- •Heart failure or arrhythmia
- •Body Mass Index > 35
- •Uncontrolled Diabetes Mellitus.
- •Evidence of Infectious Diseases.
- •Active infection
- •Malignancy
- •Pregnancy
- •Anemia less than 11g/dl or thrombocytopenia less than 100,000 or leucopenia less than
- •Unreliable patients
- •Non-resident in Jordan
研究组 & 干预措施
Extracellular vesicles (EV)
Intra-articular Extracellular vesicles injection will be given to each patient in 2 doses
干预措施: Extracellular vesicles (Biological)
结局指标
主要结局
Safety
时间窗: follow-up duration is 12 months
Measuring and evaluating the Safety and Tolerability of the intra-articular injection of extracellular vesicles: Complete Blood Count (CBC): Hemoglobin (Hb) Hematocrit (Hct) White blood cells (WBCs) Platelets (PLTs) Red blood cell indices (MCV, MCH, MCHC) A. Liver Function Tests (LFTs) Alanine aminotransferase (ALT) Asparate aminotransferase (AST) Alkaline phosphatase (ALP) Gamma-glutamyl transferase (GGT) Total bilirubin (TBIL), Direct \& Indirect bilirubin Albumin and total protein B. Kidney Function Tests Blood Urea Nitrogen (BUN) Serum Creatinine Uric Acid Estimated Glomerular Filtration Rate (eGFR) C. Electrolyte Panel Sodium (Na⁺) Potassium (K⁺) Calcium (Ca²⁺) Magnesium (Mg²⁺) Chloride (Cl-) Bicarbonate (HCO₃-) D. Glucose \& Lipid Profile Fasting blood glucose (FBG) Total cholesterol, HDL, LDL, Triglycerides Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) INR (International Normalized Ratio)
次要结局
- Efficacy(follow-up duration is 12 months)
研究者
Hanan Jafar
Principal Investigator
University of Jordan