MDS Clinical Trial
Official title:
A Pilot Trial of Unrelated Umbilical Cord Blood Transplantation Augmented With Ex Vivo CytokinePrimed ALDHbr Umbilical Cord Blood Cells
The main purpose of this investigational (not approved by the FDA) Phase I research is to test whether transplantation of umbilical cord blood cells can be safely supplemented with a transfusion of a portion of these cells that have been sorted (collected from a special machine called a cell sorter) and then either infused a few hours after the standard transplant or for some patients grown in a special system in the laboratory prior to the transplant, designed to increase the number of stem cells transplanted. This system is currently in the early phases of testing.
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)
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