drugset / Trial / NCT03545269
Study to Assess the Efficacy and Safety of Treatment of Articular Cartilage Lesions With CartiLife®
Phase 2
Completed
30 enrolled
Biosolution Co., Ltd.
Ewha Womans University · collabGangnam Severance Hospital · collabKyunghee University Medical Center · collabSeverance Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocyte (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using MRI, clinical, biochemical and International Knee Documentation Committee(IKDC) outcomes preoperatively as well as 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.
Timeline
- Start
- 2014-02-03
- Primary completion
- 2017-02-23
- Completion
- 2017-02-23
Publications
- Yoon KH, Lee J, Park JY. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation Versus Microfracture for the Treatment of Articular Cartilage Defects: A 5-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2024 Feb;52(2):362-367. doi: 10.1177/03635465231222797. Epub 2024 Jan 17.
- Yoon KH, Yoo JD, Choi CH, Lee J, Lee JY, Kim SG, Park JY. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation versus Microfracture for Repair of Articular Cartilage Defects: A Prospective Randomized Trial. Cartilage. 2021 Dec;13(1_suppl):1092S-1104S. doi: 10.1177/1947603520921448. Epub 2020 Jun 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CartiLife | Cell therapy | 1 ml | Other |