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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 (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.
Details
| Lead sponsor | Etablissement Français du Sang |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 1 |
| Start date | 2010-05 |
| Completion | 2012-02 |
Conditions
- Healthy Volunteers
Interventions
- intravenous injection of labeled cRBC
Primary outcomes
- Study of the life span in vivo of cultured Red Blood Cells. — At T+24h, T+48h and day 30
Countries
France