Analyses of Bone Marrow and Blood Samples From Healthy Volunteers: Focus on the redOx Metabolism (HEALTHOX)

Analyses of Bone Marrow and Blood Samples From Healthy Volunteers: Focus on the redOx Metabolism - HEALTHOX

Oxidative stress is defined by an excess of reactive oxygen species (reactive oxygen species or ROS) in cells. ROS are essential to cell life (proliferation, differentiation), including kinase activity via inhibition of phosphatases. Very low levels of ROS are observed in quiescent cells, including hematopoietic stem cells. Conversely, an excess of ROS can induce DNA damage that may lead to the destruction of the cell.

The level of ROS in cells is the result of production (mainly the NADPHoxydase and the mitochondrial respiratory chain) and their disposal via antioxidant enzymes. The hematology team of the university hospital of Tours (France) found that certain antioxidant enzymes are essential for the self-renewal of normal and leukemic cells such as glutathione peroxidase-3 (Herault O et al, J Exp Med 2012, 209:895). Their expression is modified in hematological diseases (patent WO2012085188A1 / 2012-06-28 and FR1000267310 / 2014-11-27).

Age potentially affects the level of expression of antioxidant genes, since it was established a decrease in glutathione peroxidase activity in women over 65 years (Sara E, J Gerontol A Biol Sci Med Sci 2008 63: 505). The study HEALTHOX will determine the impact of age on the oxidative metabolism of normal hematopoietic cells, and in particular the expression of antioxidant genes. It will provide a reference for analyzing disturbances of oxidative metabolism in blood diseases. The main objective is the comparison of peripheral blood and bone marrow cells depending from 3 groups of healthy volunteers: 18-39 years, 40-59 years and 60-85 years. The level of ROS and the expression of genes encoding the major antioxidant enzymes involved in the regulation of oxidative stress will be studied. The secondary objectives are to create a cell bank (blood and marrow), a blood plasma bank and a cDNA library (blood and marrow) from healthy volunteers.

Study Overview

• Status: Completed
• Conditions: redOx Metabolism
• Intervention / Treatment: Procedure: Blood test; Procedure: Medullar test

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • CHRU Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers
• Age ≥ 18 years old and ≤ 85 ans
• Informed and written consent
• Affiliation to Social Security

Exclusion Criteria:

• Subject with an history of hematologic disease
• Subject with an history of tumoral disease with chemotherapy or radiotherapy
• Subject with an history of infectious or inflammatory disease
• Subject taking a treatment in prevention of blood clots
• Subject under guardianship or protection measure
• Subject with in the last 30 days food supplement rich in antioxidant : ascorbic acid, trace elements, etc…
• Subject with in the last 30 days treatment with known effect on oxydative metabolism : N-Acetyl-Cysteine, etc…
• Participant to a drug study
• Pregnant woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteer; Blood test Medullar test	Procedure: Blood test; Blood test of 30mL; Procedure: Medullar test; Medullar test for 2-5mL and a smear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of oxygene reactive species	Number of oxygene reactive species by flow cytometry	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Olivier HERAULT, PhD, CHRU Tours

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: May 30, 2016
• First Posted (Estimate): June 3, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 18, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: PHAO 2016 - OH / HEALTHOX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No