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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03233074
Acronym
COSMOS
Enrollment
93
Registered
2017-07-28
Start date
2017-11-17
Completion date
2022-04-19
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Cardio-vascular Surgery, Myelodysplastic Syndromes

Keywords

Myelodysplastic Syndromes, Acute Myeloid Leukemia, Bone Marrow, Mesenchymal stromal cell, Healthy donor

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.

Interventions

OTHERBone marrow analyses

This is a non-interventional study for the constitution of a biobank of bone marrows, in order to further investigate in vitro the cellular properties of bone marrow-isolated mesenchymal stromal cells.

Sponsors

Institut de Cancérologie de la Loire
CollaboratorOTHER
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in cellular properties of mesenchymal stromal cellsDay 0Changes 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

MeasureTime frameDescription
Number of differential biomarkers in mesenchymal stromal cellsDay 0Number of differential biomarkers expressed by MDS or AML-derived mesenchymal stromal cells

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026