Development of an in Vitro Hematopoietic Culture System and Application to Myelodysplastic Syndromes. (HEMASTEM)

Myelodysplastic syndromes (MDS) are myeloid hemopathies characterized by ineffective clonal haematopoiesis, peripheral cytopenias and a predisposition to the occurrence of acute myeloid leukemias. Their diagnosis involves a cytological evaluation of the medulla, while their prognosis, in addition to extrinsic factors depending on the patient himself (age, comorbidities), intrinsic factors. The cytological evaluation is subject to a certain subjectivity since qualitative and the diagnosis is sometimes difficult in the absence of marker of clonality. More and more studies emphasize the interest of flow cytometry (CMF) in the diagnosis of SMD: by looking for qualitative and / or quantitative aberrations of the expression of membrane markers, CMF allows to establish scores Diagnosis that we have put in place within the laboratory. However, these studies are based on a static model that studies the phenotypic characteristics of patients at a given time but does not really reflect ineffective hematopoiesis. A dynamic model for in vitro reproduction of hematopoiesis would be an innovative tool for the study of SMD. This project aims to develop and standardize a system of differentiation in liquid medium of hematopoietic stem cells (CSH) in mature cells by studying each stage of the differentiation in terms of proliferation, apoptosis and phenotypic expression. HSCs will be obtained by CD34 + sorting from the medullary sample at diagnosis: the investigator will study cell proliferation, apoptosis and the acquisition of surface markers, in order to identify the quantitative and qualitative abnormalities associated with the differentiation of haematopoietic progenitors Smart. This should make it possible to identify diagnostic and prognostic factors in terms of response to treatment, acutism and survival.

Study Overview

• Status: Completed
• Conditions: Myelodysplastic Syndromes; Hematopoietic Cell Proliferation
• Intervention / Treatment: Other: Dynamic cultures of in vitro hematopoietic stem cells

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • CHU Amiens Picardie

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patient diagnosed with anemia and therefore the myelogram finds a low-risk myelodysplastic syndrome.

Description

Inclusion Criteria:

• Patient with diagnosis, major ≥18 years
• Explained in the blood disease department for cytopenia (s)
• For which diagnosis of myelodysplastic syndrome is considered
• Justifying a diagnostic bone marrow (myelogram)
• Having been informed of the progress of this study by the referring physician of the patient during the consultation and having expressed their non-opposition

Exclusion Criteria:

• High-grade myelodysplastic syndromes on IPSS score (intermediate -2 or more) on preliminary cytological analysis
• Acute mesoblastic leukemia from the outset

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control	Other: Dynamic cultures of in vitro hematopoietic stem cells; Improvement of prognostic scores used in myelodysplastic syndromes by identifying by dynamic in vitro culture of hematopoietic stem cells dynamic factors, reflections of ineffective haematopoiesis
Diagnostic patient	Other: Dynamic cultures of in vitro hematopoietic stem cells; Improvement of prognostic scores used in myelodysplastic syndromes by identifying by dynamic in vitro culture of hematopoietic stem cells dynamic factors, reflections of ineffective haematopoiesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Phenotypic aberration detectable in flow cytometry during in vitro erythroid differentiation of hematopoietic stem cells from patients with MDS	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2016
• Primary Completion (Actual): January 23, 2018
• Study Completion (Actual): January 23, 2018

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia
• Other Study ID Numbers: PI2015_843_0035

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No