NCT02736110撤回不适用
Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) for Intra-articular Delivery to Knees With Osteoarthritis
Cytori Therapeutics0 个研究点开始时间: 2014年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS)
研究概览
简要总结
This registry study will compile information from patients that are scheduled to receive or have received Adipose Derived Regenerative Cells (ADRCs) prepared by the Celution device to treat osteoarthritis in the knee.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Males or females > 18 years of age
- •Diagnosis of osteoarthritis in one or both knees with Kellgren Lawrence grade ≥ 2 at x-ray evaluation or MRI findings of degenerative changes
- •Pain with or without swelling in the affected area for >4 months
排除标准
- •Know spine or disc disease or symptomatic nerve impingement contributing to pain in the affected limb
- •History of documented nerve damage in the affected limb
- •Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test prior to procedure.
结局指标
主要结局
Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS)
时间窗: 90 days
次要结局
- Change in knee pain assessed by VAS Assessments(Days 7, 30, 90, 180 and 365)
- Change in knee function as measured by the Lower Extremity Functional Scale(Days 7, 30, 90, 180 and 365)
- Change in knee pain as assessed by the knee injury and osteoarthritis outcome score (KOOS)(Days 7, 30, 180 and 365)
- Change in knee function as assessed by the Lysholm Knee Scoring Scale(Days 7, 30, 90, 180 and 365)
- Change in knee function as measured by Tegner Activity Scale(Days 7, 30, 90, 180 and 365)
- Change in WORMS scoring (Whole Organ MRI of the knee)(Days 180 and 365)
研究者
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