NCT02846675已完成1 期
A Self-control Study: Safety and Efficacy of Autologous Adipose-Derived SVF Cells Delivered Intra-articularly in Patients With Osteoarthritis
Shanghai East Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
it's a self-control, double blind study of autologous adipose-derived stromal vascular fraction (SVF) to treat 50 osteoarthritic knees of grade II or III (K-L scale) under IRB-approved protocol in a feasibility and safety study.
详细描述
The adipose-derived SVF was obtained through disaggregation of lipoaspirate and resuspension of the SVF in 2 ml saline, with at least 50 million nucleated SVF cells and a mean viability of 85%, injected per single knee and the other knee treated with placebo.
Cell suspension and placebo will be injected using ultrasound guidance. Safety and knee function will be evaluated by questionaires monthly and MRI in every three months post-op.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade II or Grade III osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI.
- •Study Subjects must have failed a minimum of at least two conservative therapies, spanning a period of at least 3 months.
- •Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
- •Subjects will be in good health (ASA Class I-II) with a BMI <
- •Subjects must have continued pain in the knee despite conservative therapies for at least 3 months.
- •Subjects with unilateral disease must present with symptomatic knee pain using the WOMAC subscale for pain.
- •Subjects must speak, read and understand English.
- •Subjects must be reasonably able to return for multiple follow-up visits.
排除标准
- •Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study.
- •Life expectancy < 6 months due to concomitant illnesses.
- •Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- •Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have an expert consultation as to patient eligibility based on the patient's infectious status
- •Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- •Patients on chronic immunosuppressive transplant therapy
- •Systolic blood pressure (supine) ≤90 mm Hg or greater than 180mmHg
- •Resting heart rate > 100 bpm;
- •Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- •History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- •Active clinical infection
- •Unwilling and/or not able to give written informed consent.
研究组 & 干预措施
placebo treatment (the other knee)
Placebo Comparator
The other knee of subjects will be treated with placebo.
干预措施: Placebo (Biological)
SVF treatment (random knee)
Experimental
A random knee (left or right) of subjects will be treated with autologous SVF.
干预措施: autologous SVF (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 6 months
Subjects will be monitored for adverse events
次要结局
- Change in Pain Scores on the WOMAC Scale at All Follow-up Visits(1 month, 2 months, 3 months, 4 months, 5 months, 6 months)
- Change from baseline in MRI imaging(3 months & 6 months)
- Change in Function Scores on the WOMAC Scale at All Follow-up Visits(1 month, 2 months, 3 months, 4 months, 5 months, 6 months)
研究者
Yin Feng
Chief Physician
Shanghai East Hospital
研究点 (1)
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