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RecruitingPhase 1Phase 2NCT07111325

Safety and Preliminary Efficacy of iEVs Injection in Treating Lateral Epicondylitis of Humerus

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

Sponsor

Shanghai 6th People's Hospital

Enrollment

24 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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.

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Interventions

BIOLOGICALiEV

induced pluripotent stem cell-derived extracellular vesicles

BIOLOGICALPRP

PRP injection

OTHERimmobilization

immobilization

Locations(1)

Shanghai Sixth hospital

Shanghai, Shanghai Municipality, China

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NCT07111325