NCT01771471终止2 期
A Phase II, Randomized, Double Blind, Placebo Controlled Study Evaluating the Treatment of Degenerative Lumbar Discs With Allogeneic Cultured Chondrocytes
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 20
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
This is a clinical study to collect safety and preliminary efficiency information on the use of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to treat low back pain.
详细描述
This is a Phase II clinical study to collect additional safety data and preliminary efficiency of juvenile chondrocytes, delivered in fibrin carrier (NuQu®) to the nucleus of lumbar intervertebral discs for the treatment of discogenic pain. This to be accomplished through a double blinded, placebo-controlled study of clinically meaningful endpoints including validated, subject reported outcomes of pain and disability, health related quality of life and subject satisfaction with treatment.
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)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form;
- •Is at least 21 years of age;
- •Have central low back pain aggravated by movement and or postural changes (standing/sitting);
- •Have had back pain for at least 6 months, and have failed conservative management
- •One Grade III or IV (Pfirrmann Scale) degenerated lumbar disc;
排除标准
- •Current disc extrusion at any level in their lumbar spine; disc bulges or protrusions at any level in the lumbar spine resulting in nerve root compression;
- •Severe disc narrowing (equal to or more than 50% loss of disc height at the targeted level);
- •Type II or III Modic changes at any level;
- •Type I Modic changes at any level other than the targeted level;
- •Type I Modic changes at the treated level if maximum height of the changes is 25% or more of the vertebral body height;
- •Osteoporotic compression fracture at any vertebral level;
- •Lumbar Scheurmann's disease;
- •Antero or retrolisthesis ≥ 3mm at any level;
- •Currently experiencing chronic pain generating from any other source, which (in the judgment of the investigator) may interfere with the evaluation of back pain, and or disability;
- •Infection at the planned treatment site, history of systemic or local infection, which (in the investigator's judgment) may compromise subject participation and/or safety;
- •Currently diagnosed with immune-deficiency, which in the investigator's opinion may compromise subject participation and/or safety;
- •Receiving any immune-suppressant therapies other than short term steroid preparations;
- •Diagnosed with any comorbid conditions including: abnormal bleeding, AIDS, diabetes, hepatic or renal disease, and cardiopulmonary disorders such as COPD, MI and CHF; active malignancy or history of malignancy, or diseases of bone metabolism, which in the investigator's opinion may compromise subject participation and/or safety;
- •Has a history of alcoholism, medication or intravenous drug abuse, psychosis, is a prisoner, has a personality disorder(s), poor motivation, emotional or intellectual issues that would likely make the subject unreliable for the study, or 3 or more Waddell Signs of nonorganic Behavior or any combination of variables in the Investigator's judgment that should exclude a potential subject;
- •Has pending litigation against a health care professional, except where required by the insurer as a condition of coverage, personal injury compensation or litigation claims;
- •Has active or pending workers' compensation claims;
- •Has contraindications for MRI.
研究组 & 干预措施
Saline
Other
single administration
干预措施: Placebo (Other)
NuQu treatment
Experimental
single administration
干预措施: NuQu (Biological)
结局指标
主要结局
Oswestry Disability Index
时间窗: 12 months
次要结局
- Subject Satisfaction as measured by subject's willingness to have the same procedure for the same condition(24 Months)
- MRI(24 Months)
- Visual Analog Scale(24 Months)
研究者
研究点 (20)
Loading locations...
相似试验
已完成
2 期
ZD4054 (Zibotentan) Phase II Non-Small Cell Lung Cancer StudyNon Small Cell Lung CancerLung CancerNCT00745875AstraZeneca66
Unknown
2 期
Evaluate the Safety and Efficacy of AD-35 Tablet in Subjects With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT03790982Zhejiang Hisun Pharmaceutical Co. Ltd.240
已完成
2 期
MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)SchizophreniaParanoid SchizophreniaNCT00482430Merck Sharp & Dohme LLC50
终止
2 期
Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis SuppurativaHidradenitis SuppurativaNCT01838499AstraZeneca224
已完成
2 期
Investigation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of Oral Danirixin in Symptomatic COPD Subjects With Mild to Moderate Airflow Limitation at Risk for ExacerbationsPulmonary Disease, Chronic ObstructiveNCT02130193GlaxoSmithKline102