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
1 other identifier
interventional
24
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2025
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2023
CompletedFirst Posted
Study publicly available on registry
November 22, 2023
CompletedStudy Start
First participant enrolled
November 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
December 11, 2024
December 1, 2024
2 years
October 31, 2023
December 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment-emergent adverse events
The safety and tolerability of the TG-C injection for the treatment of degenerative disc disease resulting in chronic discogenic lumbar back pain will be evaluated by summarizing adverse events by treatment
6 and 12 months
Secondary Outcomes (2)
Compare pain severity using a Visual Analogue Scale
6 and 12 months
Oswestry Disability Index survey
6 and 12 months
Other Outcomes (7)
Treatment-emergent adverse events
18 and 24 months
Compare pain severity using a Visual Analogue Scale
18 and 24 months
Oswestry Disability Index survey
18 and 24 months
- +4 more other outcomes
Study Arms (4)
Active Treatment 1
ACTIVE COMPARATORLow dose TG-C 1.5 x 10e6 cells
Active Treatment 2
ACTIVE COMPARATORMiddle dose TG-C 5.0 x 10e6 cells
Active Treatment 3
ACTIVE COMPARATORHigh dose TG-C 1.5 x 10e7 cells
Sham Control
SHAM COMPARATORsingle subcutaneous injection of normal saline
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
- ODI Index \>30 and \<= 80
- Inadequate response to at least one medication (e.g., NSAID, acetaminophen, muscle relaxant) and some form of formal physical therapy over a period of at least 6 months, within 6-9 months of screening.
- Diagnosis of DDD from L1 to S1, confirmed by patient history and radiographic studies
- Modified Pfirrmann score of 3-7 on MRI
- With or without contained disc herniations of \<3 mm protrusion
- If more than 1 degenerative disc is identified. PD must be performed 30 days prior and ensure only one level is the pain generator
- BMI \>15 and \< 30 kg/m2
- Use birth control
You may not qualify if:
- 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
- Rheumatoid or psoriatic arthritis
- Compressive pathology due to stenosis or herniated or sequestered discs
- Symptomatic involvement of more than one lumber disc
- Intact disc bulge/protrusion at \>3 mm
- Lumbar intervertebral foraminal stenosis
- Previous surgery at the target disc level
- Epidural or facet joint steroid, platelet rich plasma (PRP) or bone marrow concentrate (BMC) injections, or radio frequency ablation (RFA), within 6 months prior to baseline.
- Pregnant
- Presence of ferromagnetic implants
- Involved in current or pending spinal litigations
- Care is provided under a Worker's Compensation claim
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Moon Jong Noh, PhD
Kolon TissueGene
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2023
First Posted
November 22, 2023
Study Start
November 1, 2025
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
December 11, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share