Safety Study of Unlicensed Cord Blood Units for Transplantation
This study is looking at the safety of giving unlicensed cord blood units (unlicensed CBU) from the National Cord Blood Program to patients. These cord blood units are used for transplants in people with blood disorders that are inherited, acquired, or caused by strong treatments. The main goal is to see how often patients have infusion-related reactions, which are problems that happen during or soon after the cord blood is given. These reactions can range from mild to severe. Anyone of any age or gender who needs a cord blood transplant and will receive at least one cord blood unit manufactured by the National Cord Blood Program can potentially join. The study will carefully record all problems that happen within 48 hours of the infusion.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll up to 9999 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures infusion-related reactions within 48 hours of the infusion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation
At a glance
Conditions
NCT01656603
Where you'd take part
This study runs at 71 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Abramson Cancer Center of the University of Pennsylvania Medical Center
Philadelphia, Pennsylvaniano site contact published
Recruiting
Akron Children's Hospital
Akron, Ohiono site contact published
Recruiting
Alfred I. DuPont Hospital for Children
Wilmington, Delawareno site contact published
Recruiting
All Children's Hospital, John Hopkins Medicine
St. Petersburg, Floridano site contact published
Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinoisno site contact published
Recruiting
Arthur G. James Cancer Hospital
Columbus, Ohiono site contact published
Recruiting
Barnes-Jewish Hospital at University of Washington / Sireman Cancer Center
St Louis, Missourino site contact published
Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusettsno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Eric Gehrie, MD · PRINCIPAL_INVESTIGATOR · New York Blood Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence of infusion-related reactionswithin 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.