drugset / Trial / NCT06144970

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

NCT06144970 ↗

Phase 1 Not yet recruiting 24 enrolled Kolon TissueGene, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2027-01-19
Primary completion
2028-07-28
Completion
2029-07-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator TG-C Cell therapy 1.5e+06 cells Intrathecal
Comparator TG-C Cell therapy 5e+06 cells Intrathecal
Comparator TG-C Cell therapy 1.5e+07 cells Intrathecal