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

Kolon TissueGene

Status and phase: Not yet enrolling; Phase 1

Conditions: Degenerative Disc Disease

Treatments: Biological: TG-C High Dose; Biological: Sham Control; Biological: TG-C Low Dose; Biological: TG-C Mid Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06144970

TGC-DDD-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 22 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 4 patient groups

Active Treatment 1

Active Comparator group

Description:

Low dose TG-C 1.5 x 10e6 cells

Treatment:

Biological: TG-C Low Dose

Active Treatment 2

Active Comparator group

Description:

Middle dose TG-C 5.0 x 10e6 cells

Treatment:

Biological: TG-C Mid Dose

Active Treatment 3

Active Comparator group

Description:

High dose TG-C 1.5 x 10e7 cells

Treatment:

Biological: TG-C High Dose

Sham Control

Sham Comparator group

Description:

single subcutaneous injection of normal saline

Treatment:

Biological: Sham Control