Evaluating MNV-201 for patients with low risk myelodysplastic syndromes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of MNV-201, a treatment involving autologous CD34+ cells enriched with allogenic placenta-derived mitochondria, in patients diagnosed with low risk myelodysplastic syndromes (MDS). The study aims to address the ineffective hematopoiesis and associated anemia in these patients, who are often dependent on blood transfusions. Participants must have a documented history of anemia and have exhausted existing treatment options for low risk MDS. The trial will assess the potential of this innovative cell therapy to improve blood cell production and reduce transfusion dependency.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female participants aged from 18 years old and above.
2. Low Risk MDS diagnosis with R-IPSS score of ≤3 with mutational burden and/or low burden of high-risk mutations as defined by IPSS-M.
3. Participant has anemia and is blood transfusion dependent (received 2 or more units of packed blood per /4 weeks for at least 8 weeks before enrollment).
4. A baseline natural history of the participant is available, including anemia and transfusions frequency at least 6 months before enrollment.
5. Participant has utilized all existing treatments for low risk MDS that are approved and available to him or is not medically eligible for those treatment options.
6. Participant is not eligible for Allogeneic Bone Marrow Transplantation.
7. Participant is medically able to undergo the study interventions, as determined by the investigator.
8. Participant and/or legal guardian(s) able to understand and provide voluntary written informed consent.

Exclusion criteria:

1. History of infection with HIV-1, HIV-2, or HTLV I/II.
2. Current active infection with HBV , HCV, HTLV I/II, Treponema Pallidum or HIV I-II.
3. Participant is unable to undergo apheresis.
4. Participant has known hypersensitivity to murine proteins or iron-dextran.
5. Participant has chronic severe infection.
6. Participant has disease or condition that may risk the participant or interfere with the ability to interpret the study results.
7. History of treatment for malignant disease (other than excision of non-melanoma skin cancer) in the last 2 years
8. Pregnancy or breastfeeding
9. History of treatment with gene therapy, bone marrow or allogeneic cord blood transplantation.
10. Currently participating in another clinical trial, or participation in another clinical trial within 1 year prior to study enrollment.
11. In the opinion of the Investigator, the participant is unsuitable for participating in the study for any reason.

Where it's running

• Shaare Zedek Medical Center
  Jerusalem, Israel, Israel Recruiting

Study contacts

• Study coordinator: Lea Bensoussan, MSc
• Email: lea@minoviatx.com
• Phone: 0586101291

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.