Use of Extracellular Vesicles (EV) for Knee Osteoarthrosis

Phase 1RecruitingNCT06937528

University of Jordan50 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Osteoarthrosis

Interventions

Extracellular vesiclesBIOLOGICAL

Intra-articular extravascular vesicles injection.

Eligibility

Sex: ALLMin age: 42 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Cell Therapy Center

Amman, Jordan

RECRUITING

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

Central Contacts

Hanan Jafar, PhD

CONTACT

00962798871087 hanan.jafar@gmail.com

Abdallah Awidi, MD

CONTACT

0096265355000 abdalla.awidi@gmail.com

Data from ClinicalTrials.gov

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