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
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Treatment-emergent adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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
研究组 & 干预措施
Active Treatment 1
Low dose TG-C 1.5 x 10e6 cells
干预措施: TG-C Low Dose (Biological)
Active Treatment 2
Middle dose TG-C 5.0 x 10e6 cells
干预措施: TG-C Mid Dose (Biological)
Active Treatment 3
High dose TG-C 1.5 x 10e7 cells
干预措施: TG-C High Dose (Biological)
Sham Control
single subcutaneous injection of normal saline
干预措施: Sham Control (Biological)
结局指标
主要结局
Treatment-emergent adverse events
时间窗: 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
次要结局
- Compare pain severity using a Visual Analogue Scale(6 and 12 months)
- Oswestry Disability Index survey(6 and 12 months)