Safety and Preliminary Efficacy of iEVs Injection in Treating Lateral Epicondylitis of Humerus
NCT ID: NCT07111325
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2023-07-01
2025-12-31
Brief Summary
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Detailed Description
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This randomized controlled study aims to observe whether extracellular vesicles derived from human induced pluripotent stem cells (iEVs) can promote the improvement of inflammatory status in injured extensor tendons and alleviate clinical symptoms. The study design will evaluate the efficacy by assessing changes in patients' pain, grip strength, and elbow joint function after treatment with the injection, and compare the efficacy with that of the control groups.
This is an interventional, single-center clinical study. The study plans to adopt a block randomization method without stratification. A randomization list will be generated separately for each research center by a computer, and participants will be randomly assigned to the experimental group, positive control group, and negative control group. There will be 6-12 cases in the experimental group, and 3-6 cases in each of the two control groups.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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iEV-high
1X10\^10/ml
iEV
induced pluripotent stem cell-derived extracellular vesicles
immobilization
immobilization
iEV-Low
1X10\^9/ml
iEV
induced pluripotent stem cell-derived extracellular vesicles
immobilization
immobilization
PRP
PRP
PRP
PRP injection
immobilization
immobilization
Control
immobilization
immobilization
Interventions
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iEV
induced pluripotent stem cell-derived extracellular vesicles
PRP
PRP injection
immobilization
immobilization
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Shanghai 6th People's Hospital
OTHER
Responsible Party
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Jian Ding
Doctor
Locations
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Shanghai Sixth hospital
Shanghai, Shanghai Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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2024-052
Identifier Type: -
Identifier Source: org_study_id
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