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

Study Overview
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Brief Summary
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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 and followed up with in-clinic visits and telephone calls after 12 months.

Detailed Description
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A Phase I, Double-blind, Randomized, Placebo-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. Subjects will be followed for 12 months with in-clinic visits and telephone calls after study drug administration.

Official Title
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A Phase I, Double-blind, Randomized, Placebo-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

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Biological: TG-C High Dose
* Biological: TG-C Mid Dose
* Biological: TG-C Low Dose
* Biological: Placebo Control


Participation Criteria
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Eligibility Criteria
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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 conservative medical care over 3 months 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 < 40 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 that has altered the structure of target disc Epidural or facet joint steroid, platelet rich plasma or bone marrow injections, or radio frequency ablation, 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 been treated for alcohol/drug in prior 6 months Currently incarcerated Investigator site personnel or immediate family or sponsor employee On chronic anti-coagulation therapy Tested positive on RCR testing at screening

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Treatment 1<br>Low dose TG-C 1.5 x 10e6 cells | Biological: TG-C Low Dose<br>* 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<br>|
| Active Comparator: Active Treatment 2<br>Middle dose TG-C 5.0 x 10e6 cells | Biological: TG-C Mid Dose<br>* 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<br>|
| Active Comparator: Active Treatment 3<br>High dose TG-C 1.5 x 10e7 cells | Biological: TG-C High Dose<br>* High Dose - 1 mL of the combined TG-C cells<br>|
| Placebo Comparator: Placebo Control (CS10)<br>CS10, single injection | Biological: Placebo Control<br>* 1 mL CS10<br>* Other names: CS10;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent adverse events | 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 | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare pain severity using a Visual Analogue Scale | 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. | 6 and 12 months | 
| Oswestry Disability Index survey | Survey results compared to patient baseline | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Degenerative Disc Disease