Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225095
Status:
COMPLETED
Last Update Posted:
2021-12-27
First Post:
2005-09-21
Brief Title:
A Phase III Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy
Sponsor:
Mesoblast International Sàrl
Organization:
Mesoblast Ltd
Study Overview
Official Title:
A Phase III Randomized Controlled Double Blind Study of Chondrogen - Adult Universal Cell Delivered by Intra-Articular Injection Following Meniscectomy in Patients 18-60 Years
Status:
COMPLETED
Status Verified Date:
2021-12
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:
The purpose of this study is to determine whether Chondrogen is a safe and effective post-operative treatment of the knee following menisectomy the surgical removal of all or part of a torn meniscus
Detailed Description:
Chondrogen is a preparation of adult mesenchymal stem cells MSCs in a solution containing hyaluronic acid Preclinical studies have shown that injection of Chondrogen aids in the repair of meniscal tissue following meniscectomy In Chondrogen treated subjects surgically removed meniscal tissue was regenerated cartilage surface was protected and joint damage was decreased in comparison to control subjects These benefits persisted at least one year
Three groups of recent meniscectomy patients will be followed in this study including patients that will receive placebo and patients that will be treated with one of two possible doses of Chondrogen
Three groups of recent meniscectomy patients will be followed in this study including patients that will receive placebo and patients that will be treated with one of two possible doses of Chondrogen
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