Study to Determine the Safety and Tolerability of TG-C in Subjects with Back Pain Due to Degenerative Disc Disease
NCT ID: NCT06144970
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2025-11-01
2027-11-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Treatment 1
Low dose TG-C 1.5 x 10e6 cells
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
Active Treatment 2
Middle dose TG-C 5.0 x 10e6 cells
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
Active Treatment 3
High dose TG-C 1.5 x 10e7 cells
TG-C High Dose
High Dose - 1 mL of the combined TG-C cells
Sham Control
single subcutaneous injection of normal saline
Sham Control
Single subcutaneous injection of normal saline
Interventions
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TG-C High Dose
High Dose - 1 mL of the combined TG-C cells
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
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
Sham Control
Single subcutaneous injection of normal saline
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
22 Years
70 Years
ALL
No
Sponsors
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Kolon TissueGene, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Moon Jong Noh, PhD
Role: STUDY_CHAIR
Kolon TissueGene
Central Contacts
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Other Identifiers
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TGC-DDD-101
Identifier Type: -
Identifier Source: org_study_id