Degenerative Disc DiseasePhase 1NCT06144970
Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenerative Disc Disease
A Phase 1 study testing TG-C High Dose, TG-C Mid Dose and TG-C Low Dose in people with Degenerative Disc Disease, run by Kolon TissueGene, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- TG-C High Dose, TG-C Mid Dose and TG-C Low Dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 19 Jan 2027to 28 Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
- Physical or mental conditions
- 3 or more of the 5 Waddell signs
- Positive screen for HIV
- Immediate family member of other participating patients
- Participated within 3 months or is concurrently enrolled in non-interventional research
- Transient or has a history of any substance use disorder
- Currently incarcerated
- Investigator site personnel or immediate family or sponsor employee
- On chronic anti-coagulation therapy or have confirmed coagulopathy
- Tested positive on RCR testing at screening
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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
- Degenerative Disc Disease
- Being tested
- TG-C High Dose, TG-C Mid Dose, TG-C Low Dose, Sham Control
- Keywords
- Degenerative Disc Disease
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG-C High DoseBiological
High Dose - 1 mL of the combined TG-C cells
TG-C Mid DoseBiological
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
TG-C Low DoseBiological
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
Sham ControlBiological
Single subcutaneous injection of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment 1 | Active comparator | Low dose TG-C 1.5 x 10e6 cells Receives: Biological: TG-C Low Dose |
| Active Treatment 2 | Active comparator | Middle dose TG-C 5.0 x 10e6 cells Receives: Biological: TG-C Mid Dose |
| Active Treatment 3 | Active comparator | High dose TG-C 1.5 x 10e7 cells Receives: Biological: TG-C High Dose |
| Sham Control | Sham comparator | single subcutaneous injection of normal saline Receives: Biological: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 and 12 months
Secondary outcomes (2)
Compare pain severity using a Visual Analogue Scale
Assessment of change from baseline in target back pain using the Visual Analog Scale (VAS). The VAS is a method for the assessment of the intensity of pain. The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from "0" or no pain to "100" very severe pain.
Measured: 6 and 12 months
Oswestry Disability Index survey
Survey results compared to patient baseline
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start19 Jan 2027 (estimated)
- Primary completion28 Jul 2028 (estimated)
- Study completion28 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kolon TissueGene, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moon Jong Noh, PhD, Study chair, Kolon TissueGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144970
- Sponsor's protocol ID
- TGC-DDD-101
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06144970
- Acronym / sponsor ID
- TGC-DDD-101
- Conditions
- Degenerative Disc Disease
- Keywords
- Degenerative Disc Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Kolon TissueGene, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jan 2027 (estimated)
- Primary completion
- 28 Jul 2028 (estimated)
- Study completion
- 28 Jul 2029 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Treatment 1 | Active comparator | Biological: TG-C Low DoseLow dose TG-C 1.5 x 10e6 cells |
| Active Treatment 2 | Active comparator | Biological: TG-C Mid DoseMiddle dose TG-C 5.0 x 10e6 cells |
| Active Treatment 3 | Active comparator | Biological: TG-C High DoseHigh dose TG-C 1.5 x 10e7 cells |
| Sham Control | Sham comparator | Biological: Sham Controlsingle subcutaneous injection of normal saline |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TG-C High DoseHigh Dose - 1 mL of the combined TG-C cells | Biological | Active Treatment 3 |
| TG-C Mid DoseMiddle 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 | Active Treatment 2 |
| TG-C Low DoseLow 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 | Active Treatment 1 |
| Sham ControlSingle subcutaneous injection of normal saline | Biological | Sham Control |
Primary outcome
Treatment-emergent adverse events
Time frame: 6 and 12 months
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
2 secondary outcomes
Compare pain severity using a Visual Analogue Scale
Time frame: 6 and 12 months
Oswestry Disability Index survey
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moon Jong Noh, PhD study chair
Kolon TissueGene
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TG-C High Dose, TG-C Mid Dose and TG-C Low Dose in people with Degenerative Disc Disease, run by Kolon TissueGene, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KTG Clinical ((301) 921-6000, KTGclinical@tissuegene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.