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Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenerative Disc Disease

Degenerative Disc Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06144970
Study type Interventional
Source Kolon TissueGene, Inc.
Contact Diana M Halim, MS
Phone (301) 921-6000
Email dhalim@tissuegene.com
Status Not yet recruiting
Phase Phase 1
Start date November 1, 2025
Completion date November 1, 2027
View Details
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