NCT07111325

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shanghai 6th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lateral Epicondylitis

Interventions

Type	Name	Description
BIOLOGICAL	iEV	induced pluripotent stem cell-derived extracellular vesicles
BIOLOGICAL	PRP	PRP injection
OTHER	immobilization	immobilization

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-12-01
• Completion: 2025-12-31
• First posted: 2025-08-08
• Last updated: 2025-08-08

Locations

1 site across 1 country: China