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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age22-70
SponsorKolon TissueGene, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Between the ages of >= 22 and <= 70

Provides written informed consent before undergoing any study specific procedures

Chronic lower back pain for at least 6 months. Back pain twice as great as leg pain measured using NRS

VAS between >= 40 and <= 90

Disqualifiers

Co-morbid medical condition of the spine or upper extremities

Grade 2 or higher spondylolisthesis and type III Modic changes around target disc

Suspicion of full thickness annular tear at disc

History of endocrine or metabolic disorder

Trial design

Treatments tested in this trial

  • TG-C High Dose
  • TG-C Mid Dose
  • TG-C Low Dose
  • Sham Control

Treatment groups

24 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators