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

Not Applicable

Recruiting

• Conditions: Lateral Epicondylitis
• Interventions: Biological: iEV; Biological: PRP; Other: immobilization

• Registration Number: NCT07111325
• Lead Sponsor: Shanghai 6th People's Hospital

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.

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.

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2025-07-31
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iEV-high	iEV	1X10\^10/ml
iEV-high	immobilization	1X10\^10/ml
iEV-Low	iEV	1X10\^9/ml
iEV-Low	immobilization	1X10\^9/ml
PRP	PRP	PRP
PRP	immobilization	PRP
Control	immobilization	-

Primary Outcome Measures

Name	Time	Method
Assess changes in pain levels using a Visual Analogue Scale (VAS)	From enrollment to the end of treatment at 12 weeks	Assess changes in pain levels using the Visual Analogue Scale (VAS). The scale ranges from 0 (no pain) to 10 (the most severe pain), where a higher score indicates more severe pain (worse outcome) and a lower score indicates less severe pain (better outcome).
Evaluate changes in functional outcomes through patient-rated tennis elbow assessments (PRTEE)	From enrollment to the end of treatment at 12 weeks	To assess changes in functional outcomes, the Patient-Rated Tennis Elbow Evaluation (PRTEE) is utilized. This scale encompasses 15 items, divided into two dimensions: the pain dimension (5 items) and the function dimension (10 items). It uses a 0-10 scoring system, where a higher total score indicates more severe functional impairment (worse outcome), and a lower total score indicates less severe functional impairment (better outcome).
Assess changes in functional outcomes using the Mayo Elbow Performance Score (MEPS)	From enrollment to the end of treatment at 12 weeks	To assess changes in elbow function, the Mayo Elbow Performance Score (MEPS) is employed. This scale ranges from 0 to 100, where a higher score indicates better elbow function (better outcome) and a lower score indicates worse elbow function (worse outcome).
Incidence of adverse events	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in the results of the SF-36 Quality of Life Questionnaire	From enrollment to the end of treatment at 12 weeks
Changes in functional outcomes assessed by the Subjective Elbow Value (SEV)	From enrollment to the end of treatment at 12 weeks
MRI imaging assessment at 3 months after injection	From enrollment to the end of treatment at 12 weeks

Trial Locations

Locations (1)

Shanghai Sixth hospital; 🇨🇳 Shanghai, Shanghai, China