About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
Complaints of ipsilateral muscle pain caused by other reasons in the past 6 months;
Presence of ipsilateral neurogenic, inflammatory, or systemic joint diseases;
A history of previous lateral epicondylitis (LET) surgery in the past 6 months;
Subjects deemed unsuitable for participating in the trial due to other conditions, as judged by the researcher;
Trial design
Treatments tested in this trial
- iEV
- PRP
- immobilization