Clinical trial NCT02789839: Analyses of Bone Marrow and Blood Samples From Healthy Volunteers: Focus on the redOx Metabolism
Official title: Analyses of Bone Marrow and Blood Samples From Healthy Volunteers: Focus on the redOx Metabolism - HEALTHOX
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: redOx Metabolism
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of oxygene reactive species
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: CHRU Tours
Study officials:
affiliation: CHRU TOURS
name: Olivier HERAULT, PhD
role: PRINCIPAL_INVESTIGATOR
References: