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New treatment option for Myelodysplastic Syndromes
Official title A Study to Evaluate the MNV-201 in Patients With Low Risk MDS
ClinicalTrials.gov ID: NCT06465160
What this study is testing
What is MNV-201 (Autologous CD34+ Cells Enriched with allogenic Placenta Derived Mitochondria)?
MNV-201 (Autologous CD34+ Cells Enriched with allogenic Placenta Derived Mitochondria) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for myelodysplastic syndromes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Myelodysplastic syndromes (MDS) are a group of bone marrow failures that occur when the blood-forming cells in the bone marrow become abnormal leading to an abnormal differentiation and production of one or more blood cell types. According to the American Cancer Society, in the United States, MDS occurs at a rate of 4.8 cases for every 100,000 people; MDS affects an estimated 60,000 persons in the United States, with 10,000-15,000 new cases recorded each year.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Male or female participants aged from 18 years old and above.
- 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.
- 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...
- A baseline natural history of the participant is available, including anemia and transfusions frequency at least 6 months before enrollment.
- Participant has utilized all existing treatments for low risk MDS that are approved and available to him or is not medically eligible for those...
You likely can't join if
- History of infection with HIV-1, HIV-2, or HTLV I/II.
- Current active infection with HBV , HCV, HTLV I/II, Treponema Pallidum or HIV I-II.
- Participant is unable to undergo apheresis.
- Participant has known hypersensitivity to murine proteins or iron-dextran.
- Participant has chronic severe infection.
- Participant has disease or condition that may risk the participant or interfere with the ability to interpret the study results.
See the full eligibility criteria
- Male or female participants aged from 18 years old and above.
- 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.
- 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).
- A baseline natural history of the participant is available, including anemia and transfusions frequency at least 6 months before enrollment.
- 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.
- Participant is not eligible for Allogeneic Bone Marrow Transplantation.
- Participant is medically able to undergo the study interventions, as determined by the investigator.
- Participant and/or legal guardian(s) able to understand and provide voluntary written informed consent.
- History of infection with HIV-1, HIV-2, or HTLV I/II.
- Current active infection with HBV , HCV, HTLV I/II, Treponema Pallidum or HIV I-II.
- Participant is unable to undergo apheresis.
- Participant has known hypersensitivity to murine proteins or iron-dextran.
- Participant has chronic severe infection.
- Participant has disease or condition that may risk the participant or interfere with the ability to interpret the study results.
- History of treatment for malignant disease (other than excision of non-melanoma skin cancer) in the last 2 years
- Pregnancy or breastfeeding
- History of treatment with gene therapy, bone marrow or allogeneic cord blood transplantation.
- Currently participating in another clinical trial, or participation in another clinical trial within 1 year prior to study enrollment.
- In the opinion of the Investigator, the participant is unsuitable for participating in the study for any reason.
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.