A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 9,999
- 试验地点
- 115
- 主要终点
- Incidence of infusion-related reactions
研究概览
简要总结
This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
详细描述
The primary aim of this study is to examine the safety of administration of the unlicensed investigational NCBP hematopoietic progenitor cell-cord blood (HPC-CORD BLOOD) products in a multi-institution setting. Therefore, the study will evaluate prospectively the incidence of serious adverse reactions as well as the incidence of all infusion related reactions after administration of the unlicensed, investigational NCBP CBU.
Definitions of Infusion-related adverse reactions:
Mild - Moderate: reactions during or after the infusion of the cord blood (CB) product that require some medical intervention but do not affect the overall patient status or outcome.
Severe: serious, life-threatening or fatal infusion reactions, requiring major medical intervention. These include: anaphylactic shock, acute cardiac, pulmonary or renal failure, seizures, patient transfer to the Intensive Care Unit, or death within 48 hours of the CB infusion. Adverse Reactions will also be classified by grade, according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
- •Patients: Patients of any age and either gender
- •Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)
排除标准
- •Patients who are receiving licensed cord blood products (only)
- •Patients who are receiving unlicensed cord blood products from other banks (only)
- •Patients who are transplanted at non-US transplant centers
- •Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)
研究组 & 干预措施
unlicensed CBU
The Principal Investigators will be the transplant physicians at participating US transplant centers
干预措施: unlicensed CBU (Biological)
结局指标
主要结局
Incidence of infusion-related reactions
时间窗: within 48 hours of infusion
The primary aim of this study is to examine the safety of administration of the unlicensed investigational cord blood products in a multi-institution setting. The study will evaluate prospectively the incidence of serious adverse reactions as well as the incidence of all infusion related reactions after administration of the unlicensed, investigational NCBP cord blood units.
次要结局
- engraftment(six months after transplant)