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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT04821102
Brief Summary:
The purpose of this study is to confirm cartilage regeneration through arthroscopy after a single administration of autologous Adipose Tissue derived Mesenchymal stem cells(JOINTSTEM) in patients with degenerative arthritis of K-L grade 3
Detailed Description:
JOINTSTEM is injectables for an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is cultured without additional genetic modification, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.
It primarily aims to regenerate cartilage. The intra-articular injection of JOINTSTEM is expected to stimulate the regeneration of cartilage, and to innovatively improve joint function with cartilage regeneration.
The subjects of this therapy were patients with K\&L grade 3 aged 20 or older.
This study is a double-blind, randomized, placebo controlled study with two arms to evaluate JOINTSTEM as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 21 patients will be randomly assigned into one of the following two arms in a 2:1 ratio (2 JointStem : 1 placebo control). After each patient completes 12-month visit (Visit 6) and the data management team confirms all data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.
Study:
NCT04821102
Study Brief:
Protocol Section:
NCT04821102