Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-02 @ 1:16 PM
Study NCT ID:
NCT03307668
Status:
UNKNOWN
Last Update Posted:
2017-10-12
First Post:
2017-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee
Sponsor:
Arthro-Anda Tianjin Biologic Technology Co., Ltd.
Organization:
Study Overview
Official Title:
Study on Efficacy and Safety of CaReSR-1S to Repair Cartilage Defects of the Knee: a Randomised, Multicentre, Open-label, Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
RECRUITING
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:
The purpose of this trial is to investigate the safety and effect of CaReS-1S to repair knee cartilage defects.
Detailed Description:
CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I. It is indicated for the defect filling of focal, full layer and clearly defined knee and ankle cartilage defects of longest diameter 1.1-2.2cm. The fixation of CaReSR-1S is made for all sizes with fibrin glue, whereas the 11 mm implants also allow a press-fit anchoring due to the elasticity of the implant.
The physical nature of the CaReSR-1S allows the in-growth of healthy chondrocytes, as well as progenitor cells from the surrounding healthy tissue.
The physical nature of the CaReSR-1S allows the in-growth of healthy chondrocytes, as well as progenitor cells from the surrounding healthy tissue.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: