Use of Extracellular Vesicles (EV) for Knee Osteoarthrosis

Phase 1

Recruiting

• Conditions: Knee Osteoarthrosis
• Interventions: Biological: Extracellular vesicles

• Registration Number: NCT06937528
• Lead Sponsor: University of Jordan

Brief Summary

Extracellular vesicles (EV) will be injected in patients diagnosed with Knee osteoarthrosis

Detailed Description

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.

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-02-27
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-13
• Last Update Submitted: 2025-04-13
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Primary Completion: 2026-01-30
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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 3000.
• Unreliable patients
• Non-resident in Jordan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Extracellular vesicles (EV)	Extracellular vesicles	Intra-articular Extracellular vesicles injection will be given to each patient in 2 doses

Primary Outcome Measures

Name	Time	Method
Safety	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)

Secondary Outcome Measures

Name	Time	Method
Efficacy	follow-up duration is 12 months	Measuring and evaluating the efficacy of the Intra Articular Injection of extracellular vesicles measure pain score by questionnaire: KOOS (Knee Injury and Osteoarthritis Outcome Score) Extension of WOMAC, more detailed; Domains: Pain; Symptoms; Activities of daily living (ADL); Sport and recreation; Quality of life (QoL); Scoring: 0-100 scale (0 = extreme symptoms, 100 = no symptoms); Use: Young and active OA patients, post-surgery (e.g., ACL, TKA)

Trial Locations

Locations (1)

Cell Therapy Center; 🇯🇴 Amman, Jordan