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

NCT06144970 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-12-11

No results posted yet for this study

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.

Conditions

  • Degenerative Disc Disease

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

Sponsors & Collaborators

  • Kolon TissueGene, Inc.

    lead INDUSTRY

Principal Investigators

  • Moon Jong Noh, PhD · Kolon TissueGene

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-11-01
Completion
2027-11-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06144970 on ClinicalTrials.gov