General Information |
| 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. |
| 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. |
| Clinical trials phase |
Phases 1/2 |
| Start date (estimated) |
2023-07-01 |
| End date (estimated) |
2025-12-31 |
| Clinical feature |
| Label |
epicondylitis |
| Link |
http://purl.obolibrary.org/obo/DOID_14087 |
| Description |
A bone inflammation disease that results_in inflammation located_in epicondyle. |
|
Administrative Information |
| NCT number |
NCT07111325 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT07111325 |
| Source weblink |
https://clinicaltrials.gov/study/NCT07111325 |
| Study sites |
|
| Sponsors |
Shanghai 6th People's Hospital
|
Cells |
| Which differentiated cell type is used |
| Label |
Extracellular Vesicle |
| Link |
http://purl.obolibrary.org/obo/NCIT_C153165 |
| Description |
Bilayer membrane fragments present in the blood plasma that are released by different cell types upon activation or death. Extracellular vesicles are usually classified as either exosomes (formed by the membranes of intracellular compartments, 50-100 nm in diameter) and ectosomes (also called microparticles or microvesicles, formed from plasma membrane, 100-1000 nm in diameter). |
|
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
24 |
| Contact institutions/departments |
|
