Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT00929266
Eligibility Criteria:
Inclusion Criteria:
1. 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).
2. 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 Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00929266
Study Brief:
Protocol Section:
NCT00929266