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NCT06144970 | NOT YET RECRUITING | Degenerative Disc Disease

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

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.

Condition or disease

Degenerative Disc Disease

Intervention/treatment

TG-C High Dose

TG-C Mid Dose

TG-C Low Dose

Sham Control

Phase

PHASE1

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 Type : INTERVENTIONAL
Estimated Enrollment : 24 participants
Masking : QUADRUPLE
Masking Description : Double-blind
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-11-01
Estimated Primary Completion Date : 2027-11-01
Estimated Study Completion Date : 2027-11-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 22 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Study to Determine the Safety and Tolerability of TG-C in Subjects with Back Pain Due to Degenerative Disc Disease

Location Details

NCT06144970

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