Skip to main content
Clinical Trials/NCT03233074
NCT03233074
Terminated
Not Applicable

Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and Age-matched Healthy Donors (COSMOS)

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country93 target enrollmentNovember 17, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myelodysplastic Syndromes
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
93
Locations
1
Primary Endpoint
Changes in cellular properties of mesenchymal stromal cells
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

It is of clinical significance to better characterize the intrinsic defects harbored by mesenchymal stromal cells (MSC) in Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) context, as compared to physiological conditions. Such research initiative aims to dissect the cross-talk between malignant hematopoietic stem cells (HSC) and their bone marrow (BM) partners in crime, further prospecting for innovative stromal-directed strategies for the treatment of Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

Detailed Description

Myelodysplastic syndromes (MDS) are a heterogeneous group of clonal malignancies that are characterized by ineffective hematopoiesis, progressive bone marrow failure, cytogenetic and molecular abnormalities, and increased risk for progression to acute myeloid leukemia (AML). It is a well-accepted theory that MDS and AML originate from primary alterations of hematopoietic stem cells (HSC) compartment, which confer a survival advantage to them at the expense of physiological hematopoiesis. More recently, there is growing evidences regarding the contribution of the bone marrow (BM) microenvironment to the pathogenesis of MDS and AML. Of particular interest, several studies have pointed towards a pivotal role of mesenchymal stromal cells (MSC), one of the main components of the BM niche, in the initiation and propagation of myeloid disorders. In this context, it is of clinical significance to better characterize the intrinsic defects harbored by MSC in MDS and AML context, as compared to physiological conditions. Such research initiative aims to dissect the cross-talk between malignant HSC and their BM partners in crime, further prospecting for innovative stromal-directed strategies for the treatment of MDS and AML.

Registry
clinicaltrials.gov
Start Date
November 17, 2017
End Date
April 19, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients with diagnosed myelodysplasia or acute myeloid leukemia (study place: ICLN) - Specific to the cases cohort
  • Age-matched healthy donors undergoing a cardiovascular surgery - Specific to the control cohort
  • Signed written informed consent form
  • Patient affiliated to a social security regimen or beneficiary of the same

Exclusion Criteria

  • Medical history of hematological disorders
  • Thrombocytopenia, anemia...
  • Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent (art. L.1121-6, L.112-7, L.1211-8, L.1211-9)
  • Pregnant or breastfeeding women
  • Refusing participation

Outcomes

Primary Outcomes

Changes in cellular properties of mesenchymal stromal cells

Time Frame: Day 0

Changes in cellular properties of mesenchymal stromal cells isolated from bone marrow aspirates by comparing normal cells (i.e. healthy donors) and MDS/AML cells.

Secondary Outcomes

  • Number of differential biomarkers in mesenchymal stromal cells(Day 0)

Study Sites (1)

Loading locations...

Similar Trials