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RESTORE

Title
RESTORE: Recovery and Survival of Stem Cell Originated Red Cells
RESTORE: Recovery and Survival of Stem Cell Originated Red Cells
Study Type
RESTORE: Recovery and Survival of Stem Cell Originated Red Cells
Randomised controlled phase I cross-over trial
Chief Investigator(s)
RESTORE: Recovery and Survival of Stem Cell Originated Red Cells
Dr Cedric Ghevaert
Primary Sponsor
RESTORE: Recovery and Survival of Stem Cell Originated Red Cells
NHSBT
Funder
RESTORE: Recovery and Survival of Stem Cell Originated Red Cells
NHSBT R&D Committee and NIHR BTRU Grant
NHSBT Research Theme
RESTORE: Recovery and Survival of Stem Cell Originated Red Cells
Advanced Blood Components
Summary
RESTORE: Recovery and Survival of Stem Cell Originated Red Cells

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 derived from CD34+cells isolated from adult blood vs standard donated red blood cells.

There are a small number of patients with rare blood group types for whom NHS Blood and Transplant cannot meet the transfusion requirements. New red blood cells can be grown from human blood stem cells in the laboratory. We hope that this will provide us with a novel transfusion product for these patients in the future, some of whom require regular transfusions throughout life (e.g. for thalassemia or sickle cell disease).

Study Hypothesis
RESTORE: Recovery and Survival of Stem Cell Originated Red Cells
It is hypothesised that the manufactured RBCs will have a longer survival in the circulation of the volunteers than the standard donated RBCs.
Study Design
RESTORE: Recovery and Survival of Stem Cell Originated Red Cells
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.
Study Contact
RESTORE: Recovery and Survival of Stem Cell Originated Red Cells

Nina Herbert

Email: nina.herbert@nhsbt.nhs.uk

Tel: 07590 352340