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Recruiting NCT07111325

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

Phase I / Phase II Interventional Lateral Epicondylitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iEV, PRP, immobilization.
Who it may be relevant to
Registry conditions: Lateral Epicondylitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

Lateral epicondylitis refers to pain at the lateral epicondyle of the humerus caused by chronic traumatic tendinopathic changes in the origin and insertion of the common extensor tendon on the lateral side of the elbow joint, which result from long-term and repeated loading.

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.

Interventions

  • Biological iEV
    induced pluripotent stem cell-derived extracellular vesicles
  • Biological PRP
    PRP injection
  • Other immobilization
    immobilization

Primary outcome measures

  • Assess changes in pain levels using a Visual Analogue Scale (VAS) [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Evaluate changes in functional outcomes through patient-rated tennis elbow assessments (PRTEE) [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Assess changes in functional outcomes using the Mayo Elbow Performance Score (MEPS) [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Incidence of adverse events [Time frame: From enrollment to the end of treatment at 12 weeks]
Secondary outcome measures (3)
  • Changes in the results of the SF-36 Quality of Life Questionnaire [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Changes in functional outcomes assessed by the Subjective Elbow Value (SEV) [Time frame: From enrollment to the end of treatment at 12 weeks]
  • MRI imaging assessment at 3 months after injection [Time frame: From enrollment to the end of treatment at 12 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Sixth hospital — Shanghai

Identifiers

NCT: NCT07111325 · 2024-052

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗