A Multicenter Access And Distribution Protocol For Unlicensed Cryopreserved Cord Blood Units (CBUs) For Transplantation In Pediatric And Adult Patients With Hematologic Malignancies And Other Indications

Study ID
STU 052011-121

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Niechelle Loyd
214-456-3359
niechelle.loyd@childrens.com

Principal Investigator
Victor Aquino

Summary

This is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBus) in pediatric and adult patients with hematologic malignancies and other indications. The study will enroll an unlimited number of transplant recipients at participating transplant centers based on well-defined inclusion and exclusion criteria, when the best graft source is determined to be a domestic or international CBu that does not meet FDa licensure requirements. The follow-up schedule and affiliated data collection forms for the unlicensed cord blood recipients are the standard CiBMTR data forms and procedures. all recipients receiving at least one unlicensed cord blood unit will be enrolled in the study and will be assessed for: neutrophil engraftment, serious infusion reaction, transmission of infection from CBu, survival, acute and chronic GVHD, and platelet engraftment.

Participant Eligibility

Inclusion Criteria-
-Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
-Signed informed consent (and signed assent, if applicable)
-Pediatric and adult patients of any age