Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04744402
Status:
RECRUITING
Last Update Posted:
2023-08-28
First Post:
2021-01-18
Brief Title:
Phase 2 Clinical Trial of CartiLife in the United States
Sponsor:
Biosolution Co Ltd
Organization:
Biosolution Co Ltd
Study Overview
Official Title:
A Multi-Center Open-Label Phase 2 Trial to Evaluate the Efficacy and Safety of CartiLife for Patients With Articular Cartilage Defects in the Knee
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety and efficacy of implanting pellet-type extracellular matrix-associated autologous chondrocytes CartiLife obtained by cultivating costal chondrocytes of the subject with articular cartilage defects of the knee as a result of trauma or degeneration
Detailed Description:
This open-label phase 2 study is being conducted to evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes CartiLife 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None