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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Etablissement Français du Sang
ClinicalTrials.gov Identifier:
NCT00929266
First received: June 26, 2009
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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 Intervention
Healthy Volunteers
Biological: intravenous injection of labeled cRBC

Study Type: Interventional
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

Further study details as provided by Etablissement Français du Sang:

Primary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: May 2010
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929266

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

No publications provided

Responsible Party: Etablissement Français du Sang
ClinicalTrials.gov Identifier: NCT00929266     History of Changes
Other Study ID Numbers: 2008-AO0625-50
Study First Received: June 26, 2009
Last Updated: November 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Etablissement Français du Sang:
peripheral stem cells (PSC) donors
cultured red blood cells
In vivo half life

ClinicalTrials.gov processed this record on July 24, 2014