Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06144970
PHASE1

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

Sponsor: Kolon TissueGene, Inc.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

TG-C High Dose

High Dose - 1 mL of the combined TG-C cells

BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

Sham Control

Single subcutaneous injection of normal saline