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Therapeutic Areas: Oncology | Hematology | Family Medicine
Disease Category: Hematologic Cancer
Location: United States, CA
CIBMTR 10-CBA: A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adults Patients with Hematologic Malignancies and Other Indications
You are being asked to take part in this study because you are going to have a cord blood transplant and one or more of the cord blood units that are considered by your doctor to be the best choice for your transplant may not meet all the new FDA standards. This study will allow your doctor to use these cord blood units for your transplant. Cord blood units used for transplant on this study must meet standards set by the NMDP. If a cord blood unit meets NMDP standards this means that the cord blood unit is suitable for use. This does not however guarantee that the transplant will be successful in treating your disease.
These standards include:
• Making sure the hospital where the cord blood units are collected follows safe procedures to prevent the cord blood units from coming into contact with germs.
• Making sure the cord blood units are stored and labeled in a certain way.
• Making sure the cord blood units are tested for certain viruses and bacteria that could cause illness in the recipient.
The primary purposes of this study are to:
• Provide access to cord blood units for recipients whose best choice for a cord blood unit(s) do not meet all FDA standards, but do meet standards set by the NMDP on this study.
• Assess how well and how quickly blood counts return to normal after transplant in recipients on this study.
Please take your time to make your decision about taking part in this study. You may discuss your decision with your friends and family. You can also discuss it with the medical staff at the transplant center.
You and the medical staff at your transplant center will discuss other options before you make your decision about participating in this study.
Patient Inclusion/Exclusion Criteria:
- See http://clinicaltrials.coh.org for additional information.
City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Phone: 866-896-HOPE (4673)
Research Center Information: City of Hope
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