A Pilot Trial of Unrelated Umbilical Cord Blood Transplantation Augmented With Ex Vivo CytokinePrimed ALDHbr Umbilical Cord Blood Cells
The main purpose of this study is to test whether transplantation of umbilical cord blood
cells can be safely supplemented with transfusion of a portion of these cells that have been
grown in a special system (designed to increase the number of cells transplanted) in the
laboratory prior to the transplant. This system is currently in the early phases of testing
in a FDA-IND-sponsored clinical trial. If the patient consents to participate in this
study, approximately 1/5th (20%) of the cord blood unit selected for the transplant will be
treated per protocol. The first 3 patients will receive ALDHbr sorted cells but not primed
in culture. This is to test the safety of the ALDHbr cells. The treated cells will be
given to the patient on the day of transplant approximately 4 hours after the standard or
conventional transplant which will be given from the 80% fraction of the cord blood unit. A
total of 26 evaluable patients are to be enrolled as outlined below (protocol has been
amended to allow this enrollment):
- 10 evaluable patients who received ALDHbr freshly sorted cells (20% portion)
- 10 evaluable patients who received ALDHbr sorted and cytokine primed cells (20%
portion)
- 3 evaluable patients who received a conventional cord blood unit and a cord blood unit
that has been ALDHbr sorted (sort of the UCB unit will be done on Day -1 due to the
time it takes to actually perform the sort)
- 3 evaluable patients who received a conventional cord blood unit and a cord blood unit
that has been ALDHbr sorted and cytokine primed (sort and priming will be done on day
-5 as described later in the protocol)
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety of infusing ex vivo cytokine-primed ALDHbr cells isolated from banked unrelated umbilical cord blood (CB) into patients also receiving a standard unmanipulated unrelated CB transplant delivering >2.5x10e7 nucleated cells per kg.
Prospective
Yes
Joanne Kurtzberg, MD
Principal Investigator
Duke University
United States: Food and Drug Administration
Pro00008970
NCT00692926
October 2005
July 2012
Name | Location |
---|---|
Duke University Medical Center | Durham, North Carolina 27710 |