Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT04470167
Brief Summary:
Rotator cuff tear is one of the most common shoulder diseases and conservative treatment is commonly used for tears involving ≤50% of tendon thickness. Since conventional conservative treatments are not fundamental to repair tendon tissue, there is a growing need of new therapy to improve structural outcome. This study assesses the safety and efficacy of allogeneic fibroblasts on partial-thickness rotator cuff tear. The primary outcome is change in American Shoulder and Elbow Surgeons (ASES) score at 24 weeks after TPX-115 injection. Secondary outcomes include changes from baseline in Visual Analogue Score (VAS) pain score, functional evaluations including Range of Motion (ROM), Constant Score (CS), ASES score and Simple Shoulder Test (SST) at 4, 12 and 24 weeks after administration and structural evaluation using MRI at 24 weeks after injection.
Study:
NCT04470167
Study Brief:
Protocol Section:
NCT04470167