NCT02770755撤回不适用
Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) and Healing in Muscle and Ligament Sports Injuries (ACHILLES)
Cytori Therapeutics1 个研究点 分布在 1 个国家开始时间: 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
- 试验地点
- 1
- 主要终点
- Change in magnitude of muscle tear as assessed by ultrasound or MRI
研究概览
简要总结
This registry study will compile information about patients who are scheduled to receive or have received Adipose Derived Regenerative cells (ADRCs) prepared by Celution device to treat muscle and ligament sports injuries.
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 of age
- •Patients with sports related muscle tear (≥5%) with or without ligament injury as confirmed by ultrasound or MRI with onset of injury in preceding year
- •Pain in the affected area at rest and/or movement
- •Weakness or inability to use affected muscle
排除标准
- •Muscle tear <5% or unrepaired complete tears or ruptures on ultrasound or MRI
- •Known spine or disc disease or symptomatic impingement of nerve root
- •Known neuromuscular disease (e.g., amyotrophic lateral sclerosis, muscular dystrophy)
- •History of documented nerve damage in the affected limb
- •Tears involving open wounds
- •Tears requiring surgical repair
- •Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline
结局指标
主要结局
Change in magnitude of muscle tear as assessed by ultrasound or MRI
时间窗: 42 days
次要结局
- Change in magnitude of muscle tear as assessed by ultrasound or MRI(21 days)
- % of patients with complete healing as measured by ultrasound or MRI(Days 7, 14, 21, 42 and 90)
- Change in pain(Days 7, 14, 21, 42 and 90)
- Change in function(Days 7, 14, 21, 42 and 90)
研究者
研究点 (1)
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