Actively Recruiting
Safety and Preliminary Efficacy of iEVs Injection in Treating Lateral Epicondylitis of Humerus
Led by Shanghai 6th People's Hospital · Updated on 2025-08-08
24
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Preliminary Efficacy of iEVs Injection in Treating Lateral Epicondylitis of Humerus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 provoked by at least 2 methods with a pain VAS score exceeding 3: maximum grip strength, palpation of lateral epicondyle and surrounding area, resisted dorsiflexion of wrist or middle finger, or stretching of forearm extensor muscles under pain-free grip
- Received physical therapy or non-steroidal anti-inflammatory drug treatment with poor efficacy
- Individuals with independent behavioral capacity who have signed informed consent themselves
You will not qualify if you...
- Ipsilateral muscle pain caused by other reasons in the past 6 months
- Presence of ipsilateral neurogenic, inflammatory, or systemic joint diseases
- History of lateral epicondylitis surgery in the past 6 months
- Deemed unsuitable for trial participation due to other conditions by the researcher
- MRI showing injury involving lateral collateral ligament with concurrent cartilage damage
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Sixth hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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