Use of Extracellular Vesicles (EV) for Knee Osteoarthrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Extracellular vesicles.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthrosis. Basic parameters: 42 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Jordan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Knee Osteoarthrosis (KOA) in Jordanian Patients: a Phase I Dose-finding Study Using Extracellular Vesicles (EV) for Advanced Stage III and IV KOA
Overview
Extracellular vesicles (EV) will be injected in patients diagnosed with Knee osteoarthrosis
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.
Interventions
- Biological Extracellular vesicles
Intra-articular extravascular vesicles injection.
Primary outcome measures
- Safety [Time frame: follow-up duration is 12 months]
Secondary outcome measures (1)
- Efficacy [Time frame: follow-up duration is 12 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Jordan · 1 center
- Cell Therapy Center — Amman
Identifiers
NCT: NCT06937528 · EVKneeUJCTC