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NCT Number: NCT06144970

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

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

22 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TG-C High Dose

Biological

High Dose - 1 mL of the combined TG-C cells

TG-C Mid Dose

Biological

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

Biological

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

Biological

Single subcutaneous injection of normal saline

Primary outcomes

  1. 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

Secondary outcomes

  1. Compare pain severity using a Visual Analogue Scale

    Time frame: 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.

  2. Oswestry Disability Index survey

    Time frame: 6 and 12 months

    Survey results compared to patient baseline

Other outcomes

  1. Treatment-emergent adverse events

    Time frame: 18 and 24 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. Compare pain severity using a Visual Analogue Scale

    Time frame: 18 and 24 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.

  3. Oswestry Disability Index survey

    Time frame: 18 and 24 months

    Survey results compared to patient baseline

  4. Numerical Rating Scale

    Time frame: 6, 12, 18, and 24 months

    Compare severity of lower back pain to patient baseline using a Numerical Rating Scale (NRS). Patients rate their pain at baseline and 6 and 12 months after treatment. Patients will use an eleven point numerical scale to record their pain severity with 0 being no pain and 10 being worst possible pain.

  5. Patient Global Impression of Changes

    Time frame: 6, 12, 18, and 24 months

    Patient Global Impression of Changes (PGI-C) is a 7 point scale depicting a patient's rating of overall improvement and their belief about the efficacy of treatment. The score ranges from 1 (very much worse) to 7 (very much improved)

  6. Patient-Reported Outcomes Measurement Information System

    Time frame: 6, 12, 18, and 24 months

    Patient-Reported Outcomes Measurement Information System (PROMIS) is a way to measure patient-reported outcomes (PROs), such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life. Here patients will answer a survey that consists of 16 questions that measure their physical functions after treatment. Patients will use a 5 point scale to answer the survey questions, with 1 being unable to do and 5 being without any difficulty.

  7. MRI Assessment of Structural Changes of the Spine

    Time frame: 1, 6, 12, and 24 months

    Magnetic Resonance Imaging (MRI) of the lumbar spine will be performed using a 1.5 or 3T MRI machine. The modified Pfirrmann grading system will be used to evaluate MRI signals from the nucleus and inner annular fibers. The modified Pfirrmann grading scale will be used for MRI interpretation. The grading scale uses 8 grades with 1 being uniformly hyperintense and 8 being hyperintense. MRI results will be assessed at 6 and 12 months to observe structural changes to the spine.

Study contacts

Contact information is provided by the study sponsor or research team.

Diana M Halim, MS

CONTACT

[email protected]

(301) 921-6000 ext. 187

Sponsors and collaborators

Lead sponsor

Kolon TissueGene, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Nov 22, 2023
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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