Placenta-Powered stem cells aim to treat bone marrow failure
NCT ID NCT06465160
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new cell therapy called MNV-201 for people with low-risk myelodysplastic syndrome (MDS), a bone marrow disorder that causes low blood counts. The treatment uses the patient's own blood stem cells, which are mixed with mitochondria from donated placentas to boost their energy, then infused back. The study will enroll 15 adults who need regular blood transfusions to see if the therapy is safe and can improve anemia.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MNV-201 (patient's own blood stem cells enriched with mitochondria from donated placenta)
- What this could lead to
- If it works, this could lead to a new way to treat low-risk MDS by improving blood cell production and reducing the need for blood transfusions.
- What could go wrong
- This is a very early (Phase 1) and small (15 people) trial focused on safety. It may not improve anemia or reduce transfusions, and there could be side effects from the cell infusion or the mobilization procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shaare Zedek Medical Center
RECRUITINGJerusalem, Israel, 9103102, Israel
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Can starting anemia drug sooner keep MDS patients off transfusions?
- Blood cancer registry tracks thousands to map disease course
- New drug combination targets Hard-to-Treat blood cancers
- Can a calming drug make cord blood transplants safer?
- Can a Three-Drug combo shield stem cell transplant patients from a dangerous immune attack?