Cultured Red Blood Cells : Life Span in Vivo Study (GRc2008)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00929266
Recruitment Status : Completed
First Posted : June 29, 2009
Last Update Posted : November 12, 2012
Information provided by (Responsible Party):
Etablissement Français du Sang

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 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: intravenous injection of labeled cRBC Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (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 Start Date : May 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : February 2012

Arm Intervention/treatment
Experimental: 1

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.

Primary Outcome Measures :
  1. Study of the life span in vivo of cultured Red Blood Cells. [ Time Frame: At T+24h, T+48h and day 30 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00929266

Hopital Saint Antoine, Service hématologie et therapie cellulaire
Paris, France, 75012
Sponsors and Collaborators
Etablissement Français du Sang