RecruitingPhase 1NCT06937528
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
Sponsor
University of Jordan
Enrollment
50 participants
Start Date
Jan 1, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
Extracellular vesicles (EV) will be injected in patients diagnosed with Knee osteoarthrosis
Eligibility
Min Age: 42 YearsMax Age: 75 Years
Inclusion Criteria2
- 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 Criteria12
- 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
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Interventions
BIOLOGICALExtracellular vesicles
Intra-articular extravascular vesicles injection.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06937528