Use of Extracellular Vesicles (EV) for Knee Osteoarthrosis

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06937528

Enrollment

Registered

2025-04-22

Start date

2024-01-01

Completion date

2027-01-30

Last updated

2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthrosis

Keywords

osteoarthrosis, Knee, Extracellular vesicles

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.

Interventions

BIOLOGICALExtracellular vesicles

Intra-articular extravascular vesicles injection.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

42 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Jordan

Contacts

Primary ContactHanan Jafar, PhD

hanan.jafar@gmail.com00962798871087

Backup ContactAbdallah Awidi, MD

abdalla.awidi@gmail.com0096265355000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026