Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325566
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-15
Brief Title:
Efficacy and Safety of Rexlemestrocel-L Combined With HA in Participants With Moderate to Severe Chronic Low Back Pain
Sponsor:
Mesoblast Ltd
Organization:
Mesoblast Ltd
Study Overview
Official Title:
A Prospective Multicenter Randomized Double-blind Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Combined With HA in Subjects With Moderate to Severe Chronic Low Back Pain
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT04456439
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
HyaluronicAcid
Brief Summary:
The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-LHA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-LHA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment
Detailed Description:
None
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