Status:
COMPLETED
Cultured Red Blood Cells : Life Span in Vivo Study
Lead Sponsor:
Etablissement Français du Sang
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
1. GENERALITIES 1.1 Clinical grade production of cRBC In this study the cRBC is both the active principle and the final product subjected to radioactive chromium labeling. The quantity of 5x10...
Eligibility Criteria
Inclusion
- Aptitude for donation of PSC validated according to the selection criteria for intra-familial donors of hematopoietic stem cells (HSC):
- Age \> 18 years and \< 65 years;
- Search by interview for risk factors pertaining to transmissible diseases;
- Absence of significant medical antecedents;
- Absence of severe evolutive pathology (renal, hepatic or cardiac insufficiency);
- Serological status of the following antibodies (Ab) and antigens (Ag) determined during the 30 days preceding the donation of PSC:
- anti-HIV 1+2 Ab (2 techniques)
- P24 antigenemia
- anti-HCV Ab
- HBs Ag
- anti-HBc Ab
- anti-HBs Ab
- anti-HTLV I+II Ab
- syphilis
- anti-CMV Ab
- anti-toxoplasmosis Ab
- anti-EBV Ab Determination of the blood group and search for irregular agglutinins (SIA).
- Presence in addition of the following clinical and biological characteristics required for an assay in a healthy volunteer:
- Results of the following biological tests within normal limits or clinically acceptable:
- hemogram,
- hepatic functions,
- renal functions;
- Absence of hemoglobinopathy on the hemoglobin electrophoresis profile;
- Absence of G6PD or PK deficiency;
- Absence of a radiological examination in the context of a research protocol within the last 12 months;
- Normal arterial pressure controlled after 5 min rest in a reclining position: \< 140 / 90 in three measurements at 2 min intervals;
- ECG 12 derivations with no particularity;
- Signature of a specific statement of informed consent to participate in the study of the life span of cRBC, in addition to the donation of HSC.
Exclusion
- Women of child-bearing age;
- Donors carrying markers of infection: anti-HIV 1+2 Ab (2 techniques), P24 antigenemia, anti-HCV Ab, HBs Ag, anti-HTLV I+II Ab, syphilis;
- Hemoglobinopathy;
- G6PD or PK deficiency;
- Acute or chronic systemic diseases;
- Antecedents of hypersensitivity to a drug;
- Signs, symptoms or results of biological tests lying outside the limits clinically acceptable for healthy subjects;
- Known allergy to chromium.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00929266
Start Date
May 1 2010
End Date
February 1 2012
Last Update
November 12 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital Saint Antoine, Service hématologie et therapie cellulaire
Paris, France, 75012