Safety and Preliminary Efficacy of iEVs Injection in Treating Lateral Epicondylitis of Humerus
Recruiting now · Phase 1/Phase 2
Conditions studied: Lateral Epicondylitis
In brief
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.
Key facts
- Study ID
- NCT07111325
- Run by
- Shanghai 6th People's Hospital
- People needed
- 24
- Starts
- 2023-07-01
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-08-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
- MRI showing that the injury has involved the lateral collateral ligament, with concurrent cartilage damage.
Where it is running
- Shanghai Sixth hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.