Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06144970
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-29
First Post:
2023-10-31
Brief Title:
Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenerative Disc Disease
Sponsor:
Kolon TissueGene Inc
Organization:
Kolon TissueGene Inc
Study Overview
Official Title:
A Phase I Double-blind Randomized Sham-controlled Dose-response Study Evaluating the Safety and Tolerability of TG-C in Subjects With Chronic Discogenic Lumbar Back Pain Due to Degenerative Disc Disease at 6 and 12 Months
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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 goal of this study is to evaluate the safety and tolerability of TG-C in subjects with chronic discogenic lumbar back pain due to degenerative disc disease Participants will be administered a single intradiscal injection or subcutaneous injection for sham and followed up with in-clinic visits and telephone calls for 24 months
Detailed Description:
A Phase I Double-blind Randomized Sham-controlled Dose-response Study Evaluating the Safety and Tolerability of TG-C in Subjects with Chronic Discogenic Lumbar Back Pain due to Degenerative Disc Disease at 6 and 12 Months male or female subjects with chronic discogenic lumbar back pain due to degenerative disc disease at one level TG-C is to be administered by a single intradiscal injection to the damaged disc via fluoroscopic guidance Sham will be a normal saline subcutaneous injection Subjects will be followed for 24 months with in-clinic visits and telephone calls after study drug administration
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