Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549686
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
A Phase III Study of CLS2901C in Patients With Osteoarthritis of the Knee
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Study Evaluating the Efficacy and Safety of CLS2901C in Patients With Osteoarthritis of the Knee
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the efficacy and safety of CLS2901C human allogenic chondrocyte sheets used in the osteotomy RMSC group compared to in the osteotomy alone group of patients with osteoarthritis of the knee OAK
Detailed Description:
The investigational human cellular based product is a cell sheet made by culturing and growing chondrocytes taken from cartilage tissue derived from patients with polydactyly To evaluate the efficacy and safety of CLS2901C human allogenic chondrocyte sheets used in the osteotomy RMSC group compared to in the osteotomy alone group of patients with osteoarthritis of the knee OAK Safety is evaluated by the rate of adverse events and malfunctions The evaluation period for each group will be approximately 145 months and after the completion of the 52-week evaluation patients who are available for follow-up will continue to be examined and observed for 5 years after sheets transplantation
Study Oversight
Has Oversight DMC:
None
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?:
None