NCT00929266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started May 2010

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2009

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

November 12, 2012

Status Verified

November 1, 2012

Enrollment Period

1.5 years

First QC Date

June 26, 2009

Last Update Submit

November 9, 2012

Conditions

Healthy Volunteers

Keywords

peripheral stem cells (PSC) donorscultured red blood cellsIn vivo half life

Outcome Measures

Primary Outcomes (1)

  • Study of the life span in vivo of cultured Red Blood Cells.

    At T+24h, T+48h and day 30

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

intravenous injection of labeled cRBCBIOLOGICAL

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.

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +13 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Saint Antoine, Service hématologie et therapie cellulaire

Paris, 75012, France

Location

Related Publications (2)

  • Giarratana MC, Rouard H, Dumont A, Kiger L, Safeukui I, Le Pennec PY, Francois S, Trugnan G, Peyrard T, Marie T, Jolly S, Hebert N, Mazurier C, Mario N, Harmand L, Lapillonne H, Devaux JY, Douay L. Proof of principle for transfusion of in vitro-generated red blood cells. Blood. 2011 Nov 10;118(19):5071-9. doi: 10.1182/blood-2011-06-362038. Epub 2011 Sep 1.

    PMID: 21885599DERIVED

  • Abbruzzese G, Cossu G, Balocco M, Marchese R, Murgia D, Melis M, Galanello R, Barella S, Matta G, Ruffinengo U, Bonuccelli U, Forni GL. A pilot trial of deferiprone for neurodegeneration with brain iron accumulation. Haematologica. 2011 Nov;96(11):1708-11. doi: 10.3324/haematol.2011.043018. Epub 2011 Jul 26.

    PMID: 21791473DERIVED

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

CholangitisBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2009

First Posted

June 29, 2009

Study Start

May 1, 2010

Primary Completion

November 1, 2011

Study Completion

February 1, 2012

Last Updated

November 12, 2012

Record last verified: 2012-11

Locations

FR(1)