Study to Determine the Safety and Tolerability of TG-C in Subjects With Back Pain Due to Degenerative Disc Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TG-C High Dose, TG-C Mid Dose, TG-C Low Dose, Sham Control.
- Who it may be relevant to
- Registry conditions: Degenerative Disc Disease. Basic parameters: 22 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Biological TG-C High Dose
High Dose - 1 mL of the combined TG-C cells - Biological TG-C Mid Dose
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 - Biological TG-C Low Dose
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 - Biological Sham Control
Single subcutaneous injection of normal saline
Primary outcome measures
- Treatment-emergent adverse events [Time frame: 6 and 12 months]
Secondary outcome measures (2)
- Compare pain severity using a Visual Analogue Scale [Time frame: 6 and 12 months]
- Oswestry Disability Index survey [Time frame: 6 and 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06144970 · TGC-DDD-101