Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-02 @ 8:05 PM
Study NCT ID:
NCT02539056
Status:
UNKNOWN
Last Update Posted:
2015-09-02
First Post:
2015-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte)
Sponsor:
Sewon Cellontech Co., Ltd.
Organization:
Study Overview
Official Title:
This Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte) in Patients With Cartilage Defects in Their Knees.
Status:
UNKNOWN
Status Verified Date:
2015-08
Last Known Status:
ACTIVE_NOT_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:
A clinical trial to evaluate the long-term efficacy and safety of a CHONDRON (Autologous cultured Chondrocyte) for 48weeks, and additional 96weeks in patients with cartilage defects in their knees.
Detailed Description:
This is an open trial, involving a total of 24 subjects. Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant. During the trial period, subjects must follow the instructions given by principal investigator. Subjects will make 8\* hospital visits on a regular basis inclusive of hospitalization. During these visits subjects will be examined. For the evaluation of safety and efficacy of CHONDRON, examination with doctors, blood samples, x-ray, MRI tests, observation with the naked eyes and arthroscopy will be performed. \*If tissue samples can be collected at screening visit, there will be only 7 visits.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: