Degenerative Disc Disease
Conditions
Keywords
Degenerative Disc Disease
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.
Interventions
BIOLOGICALTG-C High Dose
High Dose - 1 mL of the combined TG-C cells
BIOLOGICALTG-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
BIOLOGICALTG-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
BIOLOGICALSham Control
Single subcutaneous injection of normal saline
Sponsors
Kolon TissueGene, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
CONTACTKTG Clinical
STUDY_CHAIRMoon Jong Noh, PhD
Kolon TissueGene
Outcome results
None listed