Phase I/II, Multicenter, Open-label, Single Administration, Dose Finding, Clinical Trial to Evaluate the Safety and Tolerability of Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- DePuy Spine
- 入组人数
- 32
- 试验地点
- 8
- 主要终点
- Neurological Assessment for Motor Function and Reflexes/Sensory
研究概览
简要总结
Study to show the effectiveness and safety of a single injection of rhGDF5 into a degenerating single spinal disc in treating lumbar level degenerative disc disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent low back pain, with at least 3 months of non-surgical therapy, at one symptomatic lumbar level (L3/L4 to L5/S1) as confirmed using a standardized discography protocol
- •Oswestry Disability Index of 30 or greater
- •Low back pain score greater than or equal to 4 cm as measured by VAS, at Visit 1 baseline and on day of treatment to confirm eligibility prior to administration
排除标准
- •Persons unable to have a discogram, CT or an MRI
- •Abnormal neurological exam at baseline (e.g., radiculopathy)
- •Radicular pain
- •Leak of contrast agent during the discogram, into the epidural space (does not include leak of contrast agent along the needle track)
- •MRI findings demonstrate any of the following:· Suspected disc appears normal· >50% decrease in disc height· Modic changes, and/or· Presence of osteophytes or significant facet arthrosis
研究组 & 干预措施
Intradiscal rhGDF-5
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration.
干预措施: Intradiscal rhGDF-5 (Drug)
结局指标
主要结局
Neurological Assessment for Motor Function and Reflexes/Sensory
时间窗: 12 months
Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months. For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance. For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs.
Treatment Emergent Adverse Events- Relationship to Study Drug
时间窗: Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up
Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.
次要结局
- Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline(12 months)
- Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline(12 months)
- Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline(12 Months)
- Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline(12 Months)