Stem Cell Mobilization Potential in Patients With Aplastic Anemia in Remission
Status:
Completed
Trial end date:
2006-02-01
Target enrollment:
Participant gender:
Summary
This study will examine 1) whether it is possible to collect enough stem cells (cells
produced by the bone marrow that mature into white and red blood cells and platelets) from
patients with aplastic anemia to use for future treatment, and 2) whether patients who have
been treated successfully and relapse will benefit from autologous stem cell transfusion
(transfusion of their own stem cells).
Patients 12 years of age or older with aplastic anemia who have been successfully treated
with immunosuppressive drugs and are now in remission may be eligible for this study.
Participants will undergo a complete history and physical examination, bone marrow biopsy
(removal of a small sample of bone marrow from the hip bone) and blood tests, plus procedures
to collect stem cells, as follows:
- G-CSF (Filgrastim) administration - G-CSF will be given by injection under the skin
daily for up to 10 days. This drug causes stem cells to move from the marrow into the
blood where they can be collected more easily.
- Apheresis - Stem cells will be collected through apheresis, usually starting the 5th to
6th day of Filgrastim injections. For this procedure, whole blood is collected through a
needle in an arm vein. The blood circulates through a cell separator machine where the
white cells and stem cells are removed. The red cells, platelets and plasma are returned
to the body through a second needle in the other arm. The procedure takes about 5 hours.
Up to five procedures, done on consecutive days, may be required to collect enough cells
for transplantation. If enough cells are collected, they will be purified (treated to
remove the white blood cells) using an experimental device. Removing the lymphocytes may
reduce the chance of relapse of aplastic anemia following the stem cell transplant. The
stem cells will be frozen for later use, if needed.
- Follow-up - Participants are followed at NIH at 6-month intervals.