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

NCT06144515 | Active Not Recruiting

• 1 other identifier: MNV-007
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myelodysplastic Syndromes

Keywords

Mitochondrial; Research

Outcome Measures

Primary Outcomes (3)

• Investigate mitochondrial content and function in MDS patient-derived cells

  assays of mitochondrial content and function on whole bone marrow and HSPCs assays of hematopoietic lineages;

  1 Year

• investigate effect of mitochondrial augmentation on MDS patient-derived cells

  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., in vitro ability to differentiate to various hematopoeitic lineages, immunophenotyping and single cells studies of cells post-augmentation and post-differentiation

  1 Year

• Persistence of exogenous mtDNA after mitochondrial augmentation

  Persistence of exogenous mtDNA after in vitro or in vivo culturing

  1 year

Study Arms (1)

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

Procedure: Blood test

Interventions

Blood test PROCEDURE

Blood is collected in order to perform in vitro research: 1. If a routine blood test is performed for clinical tests, the sponsor will receive the results of the Complete blood count (CBC) and an additional blood sample from the same puncture of 20ml to maximum 40ml will be collected for this study. 2. If no routine blood test is performed for clinical tests, a CBC will be performed for the study and an additional blood sample of 20ml to maximum 40ml will be collected. Additional Bone marrow (BM) material will be obtained from the same puncture performed for routine clinical tests:

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female patients of 18 years old and up and suspected or previously diagnosed with Myelodysplastic Syndrome.

You may qualify if:

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

You may not qualify if:

• \. History of prior allogeneic hematopoietic stem cell transplantation, cell therapy, gene therapy.

Sponsors & Collaborators

• Minovia Therapeutics Ltd.: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102, Israel

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 22, 2023
• Study Start: February 9, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)