Cultured Red Blood Cells : Life Span in Vivo Study (GRc2008)
To study the in vivo life span in healthy volunteers of red blood cells generated in vitro from autologous peripheral stem cells. The study will be carried out in 4 phases :
- production in vitro of the equivalent of 1 ml of blood, i.e. 5x10e9 enucleated RBC from mononuclear cells isolated from an HSC graft obtained from a healthy volunteers donor.
- labeling of these cRBC with 51 Cr
- reinjection of the autologous cRBC
- follow up of the receivers for a maximum 33 days to measure the half-life span of the injected cells.
|Study Design:||Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||First Pilot Study Evaluating the Life Span of Autologous Cultured Red Blood Cells (cRBC) Generated From Peripheral Stem Cells in Three Healthy Volunteers - Feasibility Study|
- Study of the life span in vivo of cultured Red Blood Cells. [ Time Frame: At T+24h, T+48h and day 30 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
The choice of conducting the study in healthy volunteers and not in patients is based on the necessity to have a healthy physiological context avoiding any situation which could lead to hemolysis. As the protocol requires mobilization with a growth factor, the donors of peripheral stem cells (PSC) receive G-CSF.
Direct intravenous injection of labeled cRBC in a volume of 1 mL will be administered to the subjects.
Biological: intravenous injection of labeled cRBC
This step will take place within 2 months after stem cell collection. Direct intravenous injection of labeled cRBC in a volume of 1 mL, in a room reserved for the administration of radioactive drugs, situated in the nuclear medicine clinic and adjacent to the preparation laboratory, for regulatory reasons.
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