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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai 6th People's Hospital

About this trial

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

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • iEV
  • PRP
  • immobilization

Treatment groups

24 Participants
are divided into 4 treatment groups

Sponsors and collaborators