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临床试验/NCT01728545
NCT01728545招募中不适用

The Collection and Storage of Umbilical Cord Blood for Transplantation

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 250,000 人开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250,000
试验地点
1
主要终点
Public Cord Blood Banking

研究概览

简要总结

The goal of this study is to collect blood samples from the umbilical cords of newborn babies, as soon as they are delivered, and to place these samples in the MD Anderson Cord Blood Bank. Your sample may be included in the National Cord Blood Inventory (NCBI) which is part of the CW Bill Young Cell Transplantation Program. The NCBI is a federally-supported program to assist in the collection of cord blood. Cord blood will be made available to patients through The National Marrow Donor Program (NMDP). These samples may then be offered to MD Anderson and other institutions for patients who need a bone marrow transplant and do not have a donor. The MD Anderson Cord Blood Bank will have the rights to release cord blood units to these institutions around the world according to established bone marrow transplant donor criteria, for a fee to cover costs.

Cord blood samples that are collected and then do not meet the clinical requirements for patient use may also be used at MD Anderson or other institutions either for research or for quality purposes to improve cord blood banking procedures. If not suitable for patient use or for research purposes, the cord blood unit may be thrown away.

详细描述

The blood in an unborn baby's umbilical cord contains blood-making cells that could help treat another person with a life-threatening disease. These cord blood cells may provide cells for transplants given to patients with marrow diseases such as leukemia. These cord blood transplants can be done when a patient's cell type (human leukocyte antigen, or HLA, type) matches the cord blood type. 'Cord blood' is normally thrown away with the umbilical cord and placenta after the baby is born.

Collection of the cord blood takes place after your new baby is born and the umbilical cord has been clamped and cut in the normal way. The collection of cord blood takes place from the part of the cord that is still connected to the placenta, not to your new baby. The cord blood may be collected 'in-utero': after your baby is delivered but the placenta is still inside the uterus, or it may be collected 'ex-utero': after the placenta is delivered. The choice of which method of collection is performed will depend on the preference of your obstetrician/midwife. Neither method puts you or your baby at any risk of injury. Once the cord blood is drawn, it becomes the property of the MD Anderson Cord Blood Bank, and you will not retain any residual interests or rights to this sample.

During the delivery of your baby, your obstetrician has your health and that of your newborn baby as his or her main concern. If you agree to take part in this study, your doctor and/or the Cord Blood Bank staff will try to collect the cord blood, but your doctor's main concern will be the well being of you and your baby. Circumstances may arise which prevent the collection of your cord blood.

The cord blood that is collected will be taken to the MD Anderson Cord Blood Bank Laboratory, where it will be tested or sent out for testing to laboratories accredited for doing those tests as described below.

Just like the donation of blood for transfusion, it is important that cord blood does not carry any infections that can be passed on. When volunteers donate blood to a blood bank, they are asked to fill out a confidential questionnaire about their risks for some infections (like acquired immunodeficiency syndrome (AIDS) caused by the human immunodeficiency virus (HIV), hepatitis, and/or malaria). You will be asked questions like these in a questionnaire. You will also be asked some questions about your family medical history, to check for the chance of an inherited disease that could be passed on with the cord blood. This questionnaire will be completed within 48 hours of your baby being born, and will take about 15 minutes to complete. This questionnaire is used for screening purposes, and may result in your cord blood not being suitable for patient use, in which case the cord blood may be used for research purposes, for quality purposes (to improve cord blood banking procedures), or discarded. Your medical chart, and that of your infant, will be reviewed to help determine whether you may have a disease which could be inherited and thus transmitted with the cord blood to a transplant patient who receives it. Additionally, you will be asked about your family ethnic/racial background; this information is used to help match the cord blood to the patients.

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
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Public Cord Blood Banking

时间窗: 10 years

Collection and storage of umbilical cord blood units from normal donors for banking and ultimate transplantation into patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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