RESTORE
Recovery and survival of stem cell originated red cells
Chief investigators: Professor Cedric Ghevaert and Dr Rebecca Cardigan
Study sponsor: NHS Blood and Transplant
Funder: NHSBT Research Governance Committee and NIHR BTRU Grant
Summary
This study is a single centre randomised, controlled phase I cross-over trial in healthy volunteers to assess the recovery and survival of a mini-dose of red blood cells (RBCs) derived from CD34+cells isolated from adult blood against standard donated red blood cells.
NHS Blood and Transplant cannot meet the transfusion requirements for a small number of patients with rare blood group types. New red blood cells can be grown from human blood stem cells in the laboratory. We hope that this will provide us with a new transfusion product for these patients in the future, some of whom require regular transfusions throughout life (e.g. for thalassemia or sickle cell disease). The study is managed by NHSBT Clinical Trials Unit.
Study hypothesis
It is hypothesised that manufactured RBCs will have a longer survival in the circulation of the volunteers than the standard donated RBCs.
Study design
A randomised, single blind, cross-over design to compare the recovery and survival of red blood cells manufactured from CD34+ cells isolated from adult blood compared with standard donated red blood cells. The order in which each recipient receives the standard or manufactured red blood cells is randomised and recipients will be blinded to that order.
The trial is now closed to recruitment.