iEV injections for chronic tennis elbow (lateral epicondylitis)

A Clinical Trial Study Evaluating the Safety and Preliminary Efficacy of Human Induced Pluripotent Stem Cell-derived Extracellular Vesicles (iEVs) Injection for the Treatment of Lateral Epicondylitis of the Humerus

This trial will see if injections of extracellular vesicles made from human induced pluripotent stem cells (iEVs) can help people with chronic tennis elbow reduce pain and improve elbow function.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai 6th People's Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07111325 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with unilateral lateral epicondylitis lasting at least 12 weeks, confirmed by MRI or ultrasound, with pain VAS >3 who have not responded to physical therapy or NSAIDs and who can provide informed consent are ideal candidates.

Not a fit: Patients with ipsilateral neurogenic, inflammatory, or systemic joint disease, obvious tendon tear, recent lateral epicondylitis surgery (within 6 months), or other non-tendinopathic causes of elbow pain are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the iEV injections could reduce pain, improve grip strength and elbow function, and help resolve tendon inflammation more quickly than conservative care.

How similar studies have performed: PRP has produced mixed results in prior tennis elbow studies, and iEV injections are a novel biologic approach with very limited published human data to date.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Shanghai Sixth hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Conditions Lateral Epicondylitis; lateral epicondylitis; tennis elbow; induced pluripotent stem cell; extracellularvesicles