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

Phase 1

Not yet recruiting

• Conditions: Degenerative Disc Disease
• Interventions: Biological: TG-C Low Dose; Biological: TG-C High Dose; Biological: TG-C Mid Dose; Biological: Sham Control

• Registration Number: NCT06144970
• Lead Sponsor: Kolon TissueGene, Inc.

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.

Study Timeline

• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Study Start: 2025-11-01
• Primary Completion: 2027-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment 1	TG-C Low Dose	Low dose TG-C 1.5 x 10e6 cells
Active Treatment 3	TG-C High Dose	High dose TG-C 1.5 x 10e7 cells
Active Treatment 2	TG-C Mid Dose	Middle dose TG-C 5.0 x 10e6 cells
Sham Control	Sham Control	single subcutaneous injection of normal saline

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events	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

Secondary Outcome Measures

Name	Time	Method
Compare pain severity using a Visual Analogue Scale	6 and 12 months	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.
Oswestry Disability Index survey	6 and 12 months	Survey results compared to patient baseline