Myelodysplastic SyndromesPhase 1NCT06465160
A Study to Evaluate the MNV-201 in Patients With Low Risk MDS
A Phase 1 study testing MNV-201 (Autologous CD34+ Cells Enriched with allogenic Placenta Derived Mitochondria) in people with Myelodysplastic Syndromes, run by Minovia Therapeutics Ltd. at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- MNV-201 (Autologous CD34+ Cells Enriched with allogenic Placenta Derived Mitochondria)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- 27 May 2024to 31 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Yishai Ofran, MD, (0)2-5645462 ext. +972, yofran@szmc.org.il
Dana Darel, 0503855514 ext. +972, danada@szmc.org.il
About this study
Official title: A Phase Ib, Open Label, Single or Repeated Dose Exploration Clinical Study to Evaluate the Safety and Therapeutic Effects of Infusion of MNV-201 (Autologous CD34+ Cells Enriched With Allogenic Placenta Derived Mitochondria) in Patients With Low-Risk Myelodysplastic Syndrome
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. MDS is defined by ineffective haematopoiesis resulting in blood cytopenias (a reduction in the number of mature blood cells), and clonal instability with a risk of evolution to acute myeloid leukaemia (AML). Patients with MDS collectively have a high symptom burden and are also at risk of death from complications of cytopenias and AML. MDS is generally a disease that develops with ageing; the median age at diagnosis of MDS is ~70 years, and patients frequently have comorbid conditions. The goals of therapy for patients with MDS are to reduce disease-associated symptoms and the risk of disease progression and death, thereby improving both quality and quantity of life.
Minovia Therapeutics Ltd. ("Minovia") is a biotech company developing novel therapeutics based on its mitochondrial augmentation technology (MAT). MNV-201 is a cell therapy produced by MAT that consists of the participant's autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) enriched with allogeneic placental-derived mitochondria, manufactured in Minovia's GMP facility.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- MNV-201 (Autologous CD34+ Cells Enriched with allogenic Placenta Derived Mitochondria)
- Keywords
- Low Risk MDS, Anemia, Mitochondrial, Cell Therapy
- Medical subject headings
- Myelodysplastic Syndromes, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNV-201 (Autologous CD34+ Cells Enriched with allogenic Placenta Derived Mitochondria)Biological
The participant will undergo 5 days of mobilization by G-CSF administration (Neupogen) once a day during 5 days.
On the 5th day, and after receiving the last dose of Neupogen, the participant will undergo Apheresis to collect CD34+ cells.
MNV-201 consists of autologous CD34+ cells enriched with allogeneic placenta derived mitochondria. Autologous CD34+ cells are isolated from the participant's peripheral blood after mobilization by apheresis. Allogeneic mitochondria are isolated under aseptic conditions from healthy donor placenta, cryopreserved and qualified before use.
Each product package will consist of a ready-for-injection sterile infusion bag containing clinical grade MNV-201 product for IV infusion for a single specified (autologous) participant.
| Study group | Role | What they receive |
|---|---|---|
| Autologous CD34+ cells enriched with allogenic placenta-derived mitochondria | Experimental | Participants will receive a single or repeated dose of MNV-201 product by Infusion after 5 days of mobilization by G-CSF and an apheresis procedure. Receives: Biological: MNV-201 (Autologous CD34+ Cells Enriched with allogenic Placenta Derived Mitochondria) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment-related adverse events
Occurrence of treatment-related adverse events as assessed by CTCAE v5.0 following MNV-201 infusion, during a follow up period of 12 months following first dosing (Part 1) and 6 months following second dosing (Part 2), where relevant.
Measured: 1 year
Secondary outcomes (3)
Anemia assessment
Hemoglobin rise measured by CBC of at least 1 g/dL from baseline during a follow up period of 6- and 12-months post treatment (Part 1) or 6 months post
Measured: 1 year
Blood transfusion assessment
Reduction in frequency of blood transfusions during a follow up period of 6- and 12-months post treatment (Part 1) or 6 months post treatment (Part 2) compared to the 6 months period before treatment.
Measured: 1 year
Assessment of Quality of Life by the Functional Assessment of Cancer Therapy - Anemia
Change in health-related quality-of-life (HRQoL) assessed by the Functional Assessment of Cancer Therapy - Anemia (FACT-An) from baseline during a follow up period of 6- and 12-months post treatment (Part 1) or 6 months post treatment (Part 2).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start27 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will have two parts: a single dose arm (Part 1) and a repeat dose arm (Part 2). Part 2 of the study will be subject to FDA's approval of individual patient re-dosing, after submission of patient-specific data to the FDA for review.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minovia Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465160
- Sponsor's protocol ID
- MNV-012
- Status last verified
- Sep 2025
- First submitted
- 2 Jun 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open Label, Single or Repeated Dose Exploration Clinical Study to Evaluate the Safety and Therapeutic Effects of Infusion of MNV-201 (Autologous CD34+ Cells Enriched With Allogenic Placenta Derived Mitochondria) in Patients With Low-Risk Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT06465160
- Acronym / sponsor ID
- MNV-012
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Low Risk MDS, Anemia, Mitochondrial, Cell Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Minovia Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. MDS is defined by ineffective haematopoiesis resulting in blood cytopenias (a reduction in the number of mature blood cells), and clonal instability with a risk of evolution to acute myeloid leukaemia (AML). Patients with MDS collectively have a high symptom burden and are also at risk of death from complications of cytopenias and AML. MDS is generally a disease that develops with ageing; the median age at diagnosis of MDS is ~70 years, and patients frequently have comorbid conditions. The goals of therapy for patients with MDS are to reduce disease-associated symptoms and the risk of disease progression and death, thereby improving both quality and quantity of life.
Minovia Therapeutics Ltd. ("Minovia") is a biotech company developing novel therapeutics based on its mitochondrial augmentation technology (MAT). MNV-201 is a cell therapy produced by MAT that consists of the participant's autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) enriched with allogeneic placental-derived mitochondria, manufactured in Minovia's GMP facility.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will have two parts: a single dose arm (Part 1) and a repeat dose arm (Part 2). Part 2 of the study will be subject to FDA's approval of individual patient re-dosing, after submission of patient-specific data to the FDA for review.
| Arm | Type | Receives |
|---|---|---|
| Autologous CD34+ cells enriched with allogenic placenta-derived mitochondria | Experimental | Biological: MNV-201 (Autologous CD34+ Cells Enriched with allogenic Placenta Derived Mitochondria)Participants will receive a single or repeated dose of MNV-201 product by Infusion after 5 days of mobilization by G-CSF and an apheresis procedure. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MNV-201 (Autologous CD34+ Cells Enriched with allogenic Placenta Derived Mitochondria)The participant will undergo 5 days of mobilization by G-CSF administration (Neupogen) once a day during 5 days. On the 5th day, and after receiving the last dose of Neupogen, the participant will undergo Apheresis to collect CD34+ cells. MNV-201 consists of autologous CD34+ cells enriched with allogeneic placenta derived mitochondria. Autologous CD34+ cells are isolated from the participant's peripheral blood after mobilization by apheresis. Allogeneic mitochondria are isolated under aseptic conditions from healthy donor placenta, cryopreserved and qualified before use. Each product package will consist of a ready-for-injection sterile infusion bag containing clinical grade MNV-201 product for IV infusion for a single specified (autologous) participant. | Biological | Autologous CD34+ cells enriched with allogenic placenta-derived mitochondria |
Primary outcome
Occurrence of treatment-related adverse events
Time frame: 1 year
Occurrence of treatment-related adverse events as assessed by CTCAE v5.0 following MNV-201 infusion, during a follow up period of 12 months following first dosing (Part 1) and 6 months following second dosing (Part 2), where relevant.
3 secondary outcomes
Anemia assessment
Time frame: 1 year
Blood transfusion assessment
Time frame: 1 year
Assessment of Quality of Life by the Functional Assessment of Cancer Therapy - Anemia
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MNV-201 (Autologous CD34+ Cells Enriched with allogenic Placenta Derived Mitochondria) in people with Myelodysplastic Syndromes, run by Minovia Therapeutics Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lea Bensoussan, MSc (0586101291 ext. 972, lea@minoviatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of treatment-related adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.