Clinical trial NCT06144970: Study to Determine the Safety and Tolerability of TG-C in Subjects with Back Pain Due to Degenerative Disc Disease
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Degenerative Disc Disease
Keywords: Degenerative Disc Disease
Lead sponsor: Kolon TissueGene, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-22
Enrollment: 24
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Treatment-emergent adverse events
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Compare pain severity using a Visual Analogue Scale
timeFrame: 6 and 12 months
measure: Oswestry Disability Index survey
timeFrame: 6 and 12 months
Other outcomes:
measure: Treatment-emergent adverse events
timeFrame: 18 and 24 months
measure: Compare pain severity using a Visual Analogue Scale
timeFrame: 18 and 24 months
measure: Oswestry Disability Index survey
timeFrame: 18 and 24 months
measure: Numerical Rating Scale
timeFrame: 6, 12, 18, and 24 months
measure: Patient Global Impression of Changes
timeFrame: 6, 12, 18, and 24 months
measure: Patient-Reported Outcomes Measurement Information System
timeFrame: 6, 12, 18, and 24 months
measure: MRI Assessment of Structural Changes of the Spine
timeFrame: 1, 6, 12, and 24 months
Locations:
Study officials:
affiliation: Kolon TissueGene
name: Moon Jong Noh, PhD
role: STUDY_CHAIR
References: