Safety and Preliminary Efficacy of iEVs Injection in Treating Lateral Epicondylitis of Hum
Evaluate the safety and preliminary efficacy of human induced pluripotent stem cell-derived extracellular vesicle (iEV) injection in the treatment of lateral epicondylitis of the humerus.
| Condition(s) | Lateral Epicondylitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | Evaluate the safety and preliminary efficacy of human induced pluripotent stem cell-derived extracellular vesicle (iEV) injection in the treatment of lateral epicondylitis of the humerus. |
| Who can participate | Inclusion Criteria: * Diagnosed with lateral epicondylitis by clinical symptom examination and MRI or ultrasound, without obvious tendon tear; * Unilateral lateral elbow pain lasting for more than 12 weeks; * Pain is provoked by at least 2 of the following methods, with a pain VAS score exceeding 3: maximum grip strength, palpation of the lateral epicondyle of the elbow and surrounding area, resisted dorsiflexion of the wrist or middle finger, or stretching of the forearm extensor muscles under a pain-free grip state; * Having received physical therapy or non-steroidal anti-inflammatory drug treatment with poor efficacy; * Individuals with independent behavioral capacity, who have signed the informed consent form themselves. Exclusion Criteria: * Complaints of ipsilateral muscle pain cause |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Shanghai 6th People's Hospital |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2023-07-01 |
| NCT ID | NCT07111325 |
| Official listing | https://clinicaltrials.gov/study/NCT07111325 |