Recovery and Survival of Stem Cell Originated Red Cells - RESTORE
Research type
Research Study
Full title
A single centre, randomised, controlled, single blind phase 1 cross-over trial in healthy volunteers to assess the safety and survival of a mini-dose of red blood cells derived from CD34+ cells isolated from adult blood vs standard donated red blood cells.
IRAS ID
229563
Contact name
Cedric Ghevaert
Contact email
Sponsor organisation
NHS Blood and Transplant
Eudract number
2017-002178-38
Duration of Study in the UK
1 years, 11 months, 25 days
Research summary
Approximately 1.5 million red blood cell donations are collected by NHS Blood and Transplant and transfused each year, but there are a small number of patients with rare blood group types for whom NHS Blood and Transplant cannot always 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.
Therefore, we want to find out whether red blood cells grown in the laboratory are safe and last longer in the circulation than standard donated red blood cells. The blood cells grown in the laboratory are all young whereas in standard donated blood the red cells will be of varying ages. Studies have shown that younger red cells stay in the circulation for longer once they have been transfused. We will ask existing blood donors to donate blood especially for this study on two occasions. On one occasion we will process the blood in the normal way. On the other occasion we will take the blood stem cells and grow them in the laboratory to produce new red blood cells. Mini-doses of the red blood cells prepared in these two ways will be injected into volunteers, one type on each occasion. The cells will be labelled with a radioactive tag so that they can be detected in blood samples taken from the volunteers. The dose of radioactivity received through participation in the clinical trial is equivalent to the dose of background radiation received if living in Cornwall for 12 weeks. If the laboratory grown cells last longer than the standard donated cells this could mean that such cells would eventually reduce how often transfusions are needed in patients who are dependent on transfusions.REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/1494
Date of REC Opinion
6 Nov 2018
REC opinion
Further Information Favourable Opinion