Use of Extracellular Vesicles (EV) for Knee Osteoarthrosis

ConditionKnee Osteoarthrosis

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age42-75

SponsorUniversity of Jordan

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Sublaxation beyond 20 degrees of the bones of the knee joint

Oral anticoagulants or heparin therapy

Heart failure or arrhythmia

Body Mass Index > 35

Trial design

Design model

Single group

Treatments tested in this trial

Extracellular vesicles
Biological/Vaccine
Intra-articular extravascular vesicles injection.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Extracellular vesicles (EV)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety

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)

Time frame

follow-up duration is 12 months

Secondary outcomes

Efficacy

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)

Time frame

follow-up duration is 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Jordan

Lead sponsor

Abdalla Awidi Abbadi, MD

Collaborator

The University of Jordan