Use of Extracellular Vesicles (EV) for Knee Osteoarthrosis

NCT06937528 | Recruiting Phase 1

• 1 other identifier: EVKneeUJCTC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthrosis

Keywords

osteoarthrosis; Knee; Extracellular vesicles

Outcome Measures

Primary Outcomes (1)

• 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)

  follow-up duration is 12 months

Secondary Outcomes (1)

• Efficacy

  follow-up duration is 12 months

Study Arms (1)

Extracellular vesicles (EV)

EXPERIMENTAL

Intra-articular Extracellular vesicles injection will be given to each patient in 2 doses

Biological: Extracellular vesicles

Interventions

Extracellular vesicles BIOLOGICAL

Intra-articular extravascular vesicles injection.

Also known as: EV

Extracellular vesicles (EV)

Eligibility Criteria

• Age: 42 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jordan: lead
• Abdalla Awidi Abbadi, MD: collaborator
• The University of Jordan: collaborator

Study Sites (1)

Cell Therapy Center

Amman, 00962, Jordan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Hanan Jafar, PhD

CONTACT

00962798871087; hanan.jafar@gmail.com

Abdallah Awidi, MD

CONTACT

0096265355000; abdalla.awidi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: April 22, 2025
• Study Start: January 1, 2024
• Primary Completion: January 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)