NCT07111325 Safety and Preliminary Efficacy of iEVs Injection in Treating Lateral Epicondylitis of Humerus
| NCT ID | NCT07111325 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shanghai 6th People's Hospital |
| Condition | Lateral Epicondylitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2023-07-01 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Frequently Asked Questions
Who can join the NCT07111325 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lateral Epicondylitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07111325 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07111325 currently recruiting?
Yes, NCT07111325 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanghai 6th People's Hospital to inquire about joining.
Where is the NCT07111325 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07111325 clinical trial?
NCT07111325 is sponsored by Shanghai 6th People's Hospital. The trial plans to enroll 24 participants.