iEV injections for chronic tennis elbow (lateral epicondylitis)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, phase 1/2 randomized controlled study will test the safety and preliminary efficacy of human iPSC-derived extracellular vesicle (iEV) injections for lateral epicondylitis. Participants will be block-randomized without stratification to one of three arms: iEV injection (experimental), platelet-rich plasma (positive control), or immobilization (negative control). The study plans small cohorts (approximately 6–12 in the experimental arm and 3–6 in each control arm) and will follow patients for changes in pain, grip strength, elbow function, and markers of tendon inflammatory status using clinical exams and imaging. Safety endpoints and adverse events will be closely monitored given the early-phase nature of the intervention.

Why it matters

Who can join: the full rules

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 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's running

• Shanghai Sixth hospital
  Shanghai, Shanghai Municipality, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Effectiveness of TECAR therapy with exercise for lateral epicondylitis

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• Eccentric Exercises With Muscle Energy Technique for Lateral Epicondylitis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.