Trials / Not Yet Recruiting
Not Yet RecruitingNCT06144970
Study to Determine the Safety and Tolerability of TG-C in Subjects with Back Pain Due to Degenerative Disc Disease
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Kolon TissueGene, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-11-01
- Primary completion
- 2027-11-01
- Completion
- 2027-11-01
- First posted
- 2023-11-22
- Last updated
- 2024-12-11
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06144970. Inclusion in this directory is not an endorsement.