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Phase 3 Clinical Trial of CartiLife® in Korea

Articular Cartilage Defect Clinical Trial

Official title:
A Multi-Center, Active-Controlled, Open-Label, Phase III Trial to Compare the Efficacy and Safety for Treatment of Autologous Chondrocytes Implantation With CartiLife Versus Microfracture for Patients With Knee Chondral Defects

Clinical Trial Summary

To evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) obtained by cultivating costal chondrocytes of the subject implanted into articular cartilage defects of the knee resulting from trauma or degeneration.

Clinical Trial Description

This open-label, phase 3 study is being conducted to evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) compared with microfracture surgery in adults with articular cartilage defects due to trauma or degeneration of the knee. It is hypothesized that CartiLife® treatment will demonstrate structural regeneration and improvement in function and pain at Week 48 compared to baseline. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05051332
Study type Interventional
Source Biosolution Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 3
Start date March 19, 2020
Completion date September 30, 2024
View Details
See also
  Status Clinical Trial Phase
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Recruiting NCT05942430 - Autologous Costal Osteochondral Transplantation for Talar Osteochondral Lesions N/A
Recruiting NCT04296487 - Introduction of ACI for Cartilage Repair N/A
Recruiting NCT04744402 - Phase 2 Clinical Trial of CartiLife® in the United States Phase 2
Recruiting NCT03588975 - A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee Phase 3
Recruiting NCT03219307 - NOVOCART 3D Treatment Following Microfracture Failure Phase 3
Recruiting NCT05402072 - AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip Phase 1
Not yet recruiting NCT05651997 - Study Comparing Two Methods for the Treatment of Large Chondral and Osteochondral Defects of the Knee N/A
Completed NCT00719576 - Superiority of MACI® Versus Microfracture Treatment in Patients With Symptomatic Articular Cartilage Defects in the Knee Phase 3
Not yet recruiting NCT01984450 - A Study to Compare Two Techniques for Articular Cartilage Repair:ACIC Vs. MCIC N/A