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| Name | Class |
|---|---|
| Abdalla Awidi Abbadi, MD | UNKNOWN |
| The University of Jordan | UNKNOWN |
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Extracellular vesicles (EV) will be injected in patients diagnosed with Knee osteoarthrosis
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracellular vesicles (EV) | Experimental | Intra-articular Extracellular vesicles injection will be given to each patient in 2 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracellular vesicles | Biological | Intra-articular extravascular vesicles injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanan Jafar, PhD | Contact | 00962798871087 | hanan.jafar@gmail.com | |
| Abdallah Awidi, MD | Contact | 0096265355000 | 23960 | abdalla.awidi@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cell Therapy Center | Recruiting | Amman | 00962 | Jordan |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| follow-up duration is 12 months |