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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 or subcutaneous injection for sham and followed up with in-clinic visits and telephone calls for 24 months.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment 1 | Active Comparator | Low dose TG-C 1.5 x 10e6 cells |
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| Active Treatment 2 | Active Comparator | Middle dose TG-C 5.0 x 10e6 cells |
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| Active Treatment 3 | Active Comparator | High dose TG-C 1.5 x 10e7 cells |
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| Sham Control | Sham Comparator | single subcutaneous injection of normal saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TG-C High Dose | Biological | High Dose - 1 mL of the combined TG-C cells |
| |
| 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 |
| 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. |
| 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 | 18 and 24 months |
| Compare pain severity using a Visual Analogue Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana M Halim, MS | Contact | (301) 921-6000 | 187 | dhalim@tissuegene.com |
| Name | Affiliation | Role |
|---|---|---|
| Moon Jong Noh, PhD | Kolon TissueGene | Study Chair |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Double-blind
| 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 |
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| 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 |
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| Sham Control | Biological | Single subcutaneous injection of normal saline |
|
| 6 and 12 months |
| Oswestry Disability Index survey | Survey results compared to patient baseline | 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. |
| 18 and 24 months |
| Oswestry Disability Index survey | Survey results compared to patient baseline | 18 and 24 months |
| Numerical Rating Scale | 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. | 6, 12, 18, and 24 months |
| Patient Global Impression of Changes | 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, 12, 18, and 24 months |
| Patient-Reported Outcomes Measurement Information System | 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. | 6, 12, 18, and 24 months |
| MRI Assessment of Structural Changes of the Spine | 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. | 1, 6, 12, and 24 months |