Injection of extracellular vesicles for knee osteoarthrosis treatment
Knee Osteoarthrosis (KOA) in Jordanian Patients: a Phase I Dose-finding Study Using Extracellular Vesicles (EV) for Advanced Stage III and IV KOA
This study is testing whether injecting tiny particles called extracellular vesicles can help people with knee osteoarthritis feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 42 Years to 75 Years |
| Sex | All |
| Sponsor | University of Jordan Academic / other |
| Locations | 1 site (Amman) |
| Trial ID | NCT06937528 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves injecting extracellular vesicles (EV) into patients diagnosed with knee osteoarthrosis. A total of 50 patients, both male and female, will be enrolled based on strict inclusion and exclusion criteria. Following the injection, participants will undergo clinical assessments, laboratory investigations, and magnetic resonance imaging (MRI) of the treated knee to evaluate the effects of the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with severe knee osteoarthrosis at stage III or IV.
Not a fit: Patients with significant knee joint subluxation, those on anticoagulant therapy, or individuals with uncontrolled comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from knee osteoarthrosis.
How similar studies have performed: While the use of extracellular vesicles is a novel approach in this context, similar studies have shown promise in other applications, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amman
- Cell Therapy Center — Amman, Jordan (Recruiting)
Study contacts
- Study coordinator: Hanan Jafar, PhD
- Email: hanan.jafar@gmail.com
- Phone: 00962798871087
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.