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Study to Determine the Safety and Tolerability of TG-C in Subjects with Back Pain Due to Degenerative Disc Disease
Sponsor: Kolon TissueGene, Inc.
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.
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
Key Details
Gender
All
Age Range
22 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-11-01
Completion Date
2027-11-01
Last Updated
2024-12-11
Healthy Volunteers
No
Conditions
Interventions
TG-C High Dose
High Dose - 1 mL of the combined TG-C cells
TG-C Mid Dose
Middle Dose - A volume of 2 mL CS10 and 1 mL combined TG-C cells. 1.0 mL volume of the mixed TG-C cells is injected
TG-C Low Dose
Low Dose - A volume of 9 mL CS10 and 1 mL combined TG-C cells. 1.0 mL volume of the mixed TG-C cells is injected
Sham Control
Single subcutaneous injection of normal saline