Use of Extracellular Vesicles (EV) for Knee Osteoarthrosis

University of Jordan

Status and phase: Enrolling; Phase 1

Conditions: Knee Osteoarthrosis

Treatments: Biological: Extracellular vesicles

Study type: Interventional

Funder types: Other

Identifiers

NCT06937528

EVKneeUJCTC

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 42 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Extracellular vesicles (EV)

Experimental group

Description:

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

Treatment:

Biological: Extracellular vesicles