Collection of Samples of Bone Marrow Aspiration From Patients With Myelodysplastic Syndrome

Last updated: November 27, 2023
Sponsor: Minovia Therapeutics Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myelodysplastic Syndromes (Mds)

White Cell Disorders

Treatment

Blood test

Clinical Study ID

NCT06144515
MNV-007
  • Ages > 18
  • All Genders

Study Summary

The study Objective is to collect samples of bone marrow aspirates and peripheral blood of patients with MDS for use in non-clinical research to investigate mitochondrial function sequence and effect of mitochondrial augmentation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female patients of 18 years old and up.
  2. Suspected or previously diagnosed with Myelodysplastic Syndrome.
  3. Patient able to understand and provide voluntary written informed consent.

Exclusion

Exclusion Criteria:

  1. History of prior allogeneic hematopoietic stem cell transplantation, cell therapy, genetherapy.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Blood test
Phase:
Study Start date:
February 09, 2023
Estimated Completion Date:
December 01, 2025

Study Description

Mitochondrial dysfunction is often associated with MDS. Studies have shown mitochondrial DNA (mtDNA) mutations in different MDS subtypes; however, their role in the pathogenesis and disease progression are not yet clear. Point mutations were found in various locations in the mitochondrial genome including tRNAs, rRNAs, and mitochondrial proteins.

Mitochondrial fragmentation in hematopoietic stem and progenitor cells (HSPC) can lead to ineffective hematopoiesis in MDS, suggesting mitochondria as a therapeutic target for treating MDS.

Mitochondria augmentation therapy (MAT) is a novel cell technology where hematopoietic stem and progenitor cells (HSPCs) are augmented ex vivo with mitochondria obtained from donor cells or tissue. MAT is based on the demonstrated ability of isolated mitochondria to enter cells and impact mitochondrial function and metabolic activity in the recipient cells. The transfer of mitochondria from cell to cell has been demonstrated using extracellular vesicles, nanotubes, and micropinocytosis. Mitochondria entering cells provide copies of normal mtDNA, which can be further propagated via replication within the recipient cell and via intercellular transfer.

Research will include in vitro and in vivo studies with the bone marrow sample, including, among other, the following: mitochondrial augmentation of bone marrow aspiration and/or subpopulations of cells (e.g. CD34+) isolated from the bone marrow aspiration; differentiation of augmented and/or non-augmented bone marrow aspiration and/or subpopulations of cells into hematopoietic lineages (e.g. erythroid, megakaryocyte, etc); assays of mitochondrial content and function; assays of hematopoietic lineages; culture of augmented and/or non-augmented bone marrow aspiration and/or subpopulations; cryopreservation of augmented and/or non-augmented bone marrow aspiration and/or subpopulations; sequencing of mitochondrial DNA and nuclear DNA; in vivo studies of engraftment, biodistribution and function of augmented and/or non-augmented bone marrow aspiration and/or subpopulations of cells isolated from the bone marrow aspiration.

Research will include in vitro studies with the peripheral blood sample, including, among other, the following: immunophenotyping of peripheral blood cells and immune-related functional assays; mitochondrial content and function of peripheral blood cells.

Connect with a study center

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Active - Recruiting

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