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NCT Number: NCT06937528

Use of Extracellular Vesicles (EV) for Knee Osteoarthrosis

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

Recruiting

Interested in participating?

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Key information

Conditions

Knee Osteoarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

42 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracellular vesicles

Biological

Intra-articular extravascular vesicles injection.

Other names: EV

Primary outcomes

  1. Safety

    Time frame: 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 outcomes

  1. Efficacy

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Abdallah Awidi, MD

CONTACT

[email protected]

0096265355000 ext. 23960

Hanan Jafar, PhD

CONTACT

[email protected]

00962798871087

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Collaborators

  • Abdalla Awidi Abbadi, MD

Registry information

Official study title

Knee Osteoarthrosis (KOA) in Jordanian Patients: a Phase I Dose-finding Study Using Extracellular Vesicles (EV) for Advanced Stage III and IV KOA

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 22, 2025
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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