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Tests treatment safety and results for Infusion Reactions
Official title Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation
ClinicalTrials.gov ID: NCT01656603
What this study is testing
What is unlicensed CBU?
unlicensed CBU is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for infusion reactions.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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)
You likely can't join if
- 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.)
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Duarte, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Wilmington, Delaware, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- St. Petersburg, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Maywood, Illinois, United States
- Zion, Illinois, United States
+ 36 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Duarte, California, United States; La Jolla, California, United States; Los Angeles, California, United States and 50 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.