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Tests treatment safety and results for Lateral Epicondylitis
Official title Safety and Preliminary Efficacy of iEVs Injection in Treating Lateral Epicondylitis of Humerus
ClinicalTrials.gov ID: NCT07111325
What this study is testing
What is iEV?
iEV is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for lateral epicondylitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Having received physical therapy or non-steroidal anti-inflammatory drug treatment with poor how well it works;
- Individuals with independent behavioral capacity, who have signed the informed consent form themselves.
You likely can't join 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;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.