Use of Extracellular Vesicles (EV) for Knee Osteoarthrosis

April 13, 2025 updated by: Hanan Jafar, University of Jordan

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extracellular vesicles (EV)
Intra-articular Extracellular vesicles injection will be given to each patient in 2 doses
Biological: Extracellular vesicles
Intra-articular extravascular vesicles injection.
Other Names:
  • EV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
follow-up duration is 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
follow-up duration is 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Collaborators

Abdalla Awidi Abbadi, MD
The University of Jordan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

April 13, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 13, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVKneeUJCTC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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