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:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT04368806
Brief Summary:
This study is a double-blind, randomized, placebo controlled, multi-center, superiority study to evaluate the efficacy and safety of JointStem, autologous adipose tissue derived mesenchymal stem cells (AdMSC), in patients diagnosed as knee osteoarthritis. Following a 2-week screening period, approximately 140 subjects will be randomly assigned into one of the following two arms in a 1:1 ratio (1 JointStem : 1 Placebo). After each subject completes 48-Weeks visit (Visit 8) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.
Detailed Description:
Study Procedures:
* Visit 1 (Week -7) - Screening
* Visit 2 (Week -5) - Baseline and Randomization (Lipoaspiration)
* Visit 3 (Week 0) - Treatment (Intra-articular injection)
* Visit 4 (Week 4) - 4 weeks follow-up
* Visit 5 (Week 12) - 12 weeks follow-up
* Visit 6 (Week 24) - 24 weeks follow-up
* Visit 7 (Week 36) - 36 weeks follow-up
* Visit 8 (Week 48) - 48 weeks follow-up (End of Study)
Study:
NCT04368806
Study Brief:
Protocol Section:
NCT04368806