Biological Cell Therapy for the Treatment of Patients With Thoracic & Cardiovascular Disease
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Safety - MACE - Death, Readmission, Reintervention
研究概览
简要总结
This is the clinical registry of cell based therapies that is available to researchers around the world. The registry is web based. All researches must provide IRB approval to the coordinating site- University of Utah in order to obtain access to the registry. The are predetermined case report forms for cardiovascular diseases that are currently in clinical trials- including demographics, safety, and possible efficacy end-points. All investigators have access to their own data. The servers are U.S. HIPPA compliant and protected with secure back-up.
详细描述
The clinical cell registry includes data on thoracic and cardiovascular diseases including:
Acute myocardial infarction, Chronic Angina, Heart Failure, Wound Healing including Sternal, Peripheral Arterial Disease, Critical Limb Ischemia, Type 2 Diabetes, COPD, Asthma. Neurological disorders registry is available to specifics sites if requested. Our own biological data at the University of Utah including co-localized data with Society of Thoracic Surgeons also is a part of this program. Cell based therapies that are autologous and allogeneic are included in the registry
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age >=18 years old
- •Approved consent to be enrolled in trial/registry
排除标准
- •Prior malignancy in the 5 years before treatment in this study (other than curatively treated carcinoma in-situ of the cervix or non-melanoma skin cancer)
- •Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent
研究组 & 干预措施
cell therapy
Patient receiving active biologic
干预措施: cell therapy (Biological)
control
Patient receiving placebo or standard of care
干预措施: cell therapy (Biological)
结局指标
主要结局
Safety - MACE - Death, Readmission, Reintervention
时间窗: 1 year
次要结局
未报告次要终点
研究者
Amit N. Patel MD MS
Amit Patel
Amit, Patel N, M.D.