[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Minovia Therapeutics Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":119},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,71,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100551828","phase-1-a-study-to-evaluate-the-mnv-201-in-patients-with-low-risk-mds-100551828",false,"NCT06465160","A Study to Evaluate the MNV-201 in Patients With Low Risk MDS","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","Inclusion Criteria:\n\n1. Male or female participants aged from 18 years old and above.\n2. Low Risk MDS diagnosis with R-IPSS score of ≤3 with mutational burden and\u002For low burden of high-risk mutations as defined by IPSS-M.\n3. Participant has anemia and is blood transfusion dependent (received 2 or more units of packed blood per \u002F4 weeks for at least 8 weeks before enrollment).\n4. A baseline natural history of the participant is available, including anemia and transfusions frequency at least 6 months before enrollment.\n5. 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.\n6. Participant is not eligible for Allogeneic Bone Marrow Transplantation.\n7. Participant is medically able to undergo the study interventions, as determined by the investigator.\n8. Participant and\u002For legal guardian(s) able to understand and provide voluntary written informed consent.\n\nExclusion criteria:\n\n1. History of infection with HIV-1, HIV-2, or HTLV I\u002FII.\n2. Current active infection with HBV , HCV, HTLV I\u002FII, Treponema Pallidum or HIV I-II.\n3. Participant is unable to undergo apheresis.\n4. Participant has known hypersensitivity to murine proteins or iron-dextran.\n5. Participant has chronic severe infection.\n6. Participant has disease or condition that may risk the participant or interfere with the ability to interpret the study results.\n7. History of treatment for malignant disease (other than excision of non-melanoma skin cancer) in the last 2 years\n8. Pregnancy or breastfeeding\n9. History of treatment with gene therapy, bone marrow or allogeneic cord blood transplantation.\n10. Currently participating in another clinical trial, or participation in another clinical trial within 1 year prior to study enrollment.\n11. In the opinion of the Investigator, the participant is unsuitable for participating in the study for any reason.","ALL","18 Years","100 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","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.\n\nMinovia 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.",[27],"Myelodysplastic Syndromes",[29,30,31,32],"Low Risk MDS","Anemia","Mitochondrial","Cell Therapy","RECRUITING","2025-09-25",{"date":36,"type":37},"2025-10-01","ACTUAL",{"date":39,"type":37},"2024-05-27",{"date":41,"type":21},"2029-12-31",{"name":43,"class":44},"Minovia Therapeutics Ltd.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":45},"100552516","collection-of-blood-and-skin-samples-from-patients-with-primary-mitochondrial-diseases-and-healthy-volunteers-100552516","NCT06474104","Collection of Blood and Skin Samples From Patients With Primary Mitochondrial Diseases and Healthy Volunteers","Inclusion Criteria:\n\n1. Male or female, age 3 to 85 years.\n2. For patients with Primary Mitochondrial Disease:\n\n   a. Clinical diagnosis of PMD confirmed by mtDNA sequencing.\n3. For Healthy Volunteers:\n\n   1. Normal Vital signs and BMI for age\n   2. No active medical conditions or diseases\n   3. No current medications, other than acetaminophen and naproxen sodium\n4. For All Subjects:\n\n   1. No viral or bacterial illness in past 2 weeks\n   2. No antibiotic or antiviral medications in past 2 weeks\n   3. No blood transfusion in past 2 weeks\n   4. No current pregnancy\n   5. Not currently breastfeeding\n   6. Alcohol use less than 2 drinks \u002F day\n   7. No recreational or illicit drug use in previous 1 year\n   8. No tobacco or nicotine containing products in previous 1 year\n5. Patient, parent or guardian able to understand and provide voluntary written informed consent.\n\nExclusion Criteria:\n\n1\\. History of prior treatment with allogeneic hematopoietic stem cell transplantation, or gene therapy.",true,"3 Years","85 Years",{"count":56,"type":21},100,"OBSERVATIONAL","Mitochondrial diseases are a genetically diverse group of disorders, some of which are caused by mutations or deletions in the mitochondrial DNA (mtDNA) and which display a wide range of severity and phenotypes. Despite a prevalence of roughly 1 in 8500 in the population there is no effective treatments for the majority of mitochondrial diseases beyond supportive care (Gorman 2016, Elliott 2008). Many of these, such as Pearson syndrome and Kearns-Sayre syndrome, are early onset disorders, and may lead to mortality within the first decades of life. Importantly, mitochondria are selectively inherited from the mother. In addition, there are numerous diseases in which mitochondrial dysfunction plays an important role. Some examples are Alzheimer's and Parkinson's disease, both of which are known to have mitochondrial involvement.\n\nMinovia therapeutics develops a therapeutic intervention called mitochondrial augmentation technology (MAT). For the development work, Minovia needs patients' cells with different mutations that will allow to study the baseline heteroplasmy and functionality of patient hematopoietic cells, identify potential biomarkers to assess mitochondrial content and function in liquid biopsies, and study the efficacy of MAT in different PMDs.",[60],"Primary Mitochondrial Diseases",[31,62,63,64],"Research","PMD","Rare Diseases",{"date":36,"type":37},{"date":67,"type":37},"2024-05-12",{"date":69,"type":21},"2027-05-30",{"name":43,"class":44},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":17,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":45},"100517463","phase-2-evaluate-the-safety-and-therapeutic-effects-of-a-single-intravenous-infusion-iv-of-autologous-cd34-cells-enriched-with-allogenic-placenta-derived-mitochondria-in-patients-with-a-diagnosis-of-pearson-syndrome-ps-100517463","NCT06017869","Evaluate the Safety and Therapeutic Effects of a Single Intravenous Infusion (IV) of Autologous CD34+ Cells Enriched With Allogenic Placenta-derived Mitochondria in Patients With a Diagnosis of Pearson Syndrome (PS)","PHASE II, OPEN LABEL, SINGLE DOSE STUDY OF THE SAFETY AND EFFICACY OF MNV-201 FOR THE TREATMENT OF PEARSON SYNDROME","Inclusion Criteria:\n\n1. Male or female participants aged from 1 to 18 years old.\n2. Diagnosis of Pearson Syndrome (current or history) as verified by molecular identification of deletion in mtDNA of peripheral blood. Participants are diagnosed with PS Participant can be in either the PS manifestations of the disease or may have transitioned to Kearns Sayre Syndrome (KSS) manifestations but has a history of PS.\n3. Participants have failure to thrive (height SDS smaller than -1)\n4. Participants should have at least 12 months' history of body weight and height and calculated GFR (from creatinine) before treatment.\n5. Body weight ≥ 10 kg.\n6. Participants' living parent(s) and\u002For legal guardian(s) able to understand and provide voluntary written informed consent.\n7. Participants' parents or legal guardian have a good understanding of the study and nature of the procedure and are expected to be able to comply with study visit schedules and caregiver assessments without difficulty.\n8. Participants' parents or legal guardian provides written informed consent prior to study participation.\n9. Participants are medically able to undergo the study interventions as determined by the Investigator.\n\nExclusion criteria:\n\n1. History of infection with HIV-1, HIV-2, or HTLV I\u002FII.\n2. Participants have any active infection.\n3. Participants have been diagnosed with Myelodysplastic Syndrome, by FISH and\u002For karyotype.\n4. Participants are unable to undergo apheresis.\n5. Participants have known hypersensitivity to murine proteins or iron-dextran.\n6. Participants have severe chronic infection.\n7. Participants have disease or conditions that may risk the participant or interfere with the ability to interpret the study results.\n8. History of malignancy.\n9. History of treatment with gene therapy, allogeneic bone marrow or cord blood transplantation.\n10. Participants have had a change in growth hormone regimen in less than 2 years prior to treatment.\n11. Participants have participated in another clinical trial or received other experimental medications outside a clinical trial within 1 month prior to start of this study.\n12. Participants who are pregnant or intend to become pregnant in the next 12 months.\n13. In the opinion of the Investigator, the participant is unsuitable for participating in the study for any reason.","1 Year",{"count":80,"type":21},6,[82],"PHASE2","Primary Mitochondrial diseases are a clinically and genetically heterogeneous group of disorders caused by mutations in genes encoded by nuclear Deoxyribonucleic Acid (DNA) or by mutations and\u002For deletions in the mitochondrial DNA (mtDNA). While some mitochondrial disorders only affect a single organ (e.g., the eye in Leber hereditary optic neuropathy \\[LHON\\]), many involve multiple organs. Mitochondrial disorders may present at any age and a frequent feature is the increasing number of organs involved in the course of the disease.\n\nMinovia 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.",[85,86],"Mitochondrial Diseases","Pearson Syndrome",[88,31,89,90,91],"Autologous","Pearson","Transplantation","Stem cell","2025-06-17",{"date":94,"type":37},"2025-06-22",{"date":96,"type":37},"2023-07-31",{"date":98,"type":21},"2027-12",{"name":43,"class":44},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":52,"sex":106,"minAge":17,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":45},"100344272","collection-of-donated-placenta-for-isolation-of-mitochondria-for-research-and-for-future-use-in-mitochondrial-augmentation-therapies-100344272","NCT03762512","Collection of Donated Placenta for Isolation of Mitochondria for Research and for Future Use in Mitochondrial Augmentation Therapies","Inclusion Criteria:\n\n1. Healthy pregnant females between the age of 18-45, judged to be medically eligible by the Investigator and the Sponsor's Medical Monitor.\n2. Planned elective C-section at weeks 36-41 of pregnancy.\n3. Uncomplicated pregnancy as determined by the Investigator.\n4. Available Medical History of the donor (diagnosis, diseases, medication etc…)\n\nExclusion Criteria:\n\n1. Donor is positive for a communicable disease, such as: HBV, HCV, HIV 1\\&2, WNV, HTLV 1\\&2, Treponema pallidum, CMV, Chagas, Chlamydia Trachomatis, Neisseria Gonorrhea, or any other tests required by the medical facility, IMoH, FDA, EMA or the Sponsor.\n2. Donor is at risk for a communicable disease as assessed by medical history, medical records, physical exam, and the Donor Screening Questionnaire.\n3. Donor is at risk for COVID-19 as assessed by medical history, medical records, physical exam, and the COVID-19 Screening Questionnaire.\n4. Donor smokes more than one pack of cigarettes a day or drinks more than one alcoholic beverage a day.\n5. Donor has taken a medication with potential mitochondrial effects within 2 weeks prior to placental donation, such as valproic acid, aminoglycoside antibiotics, neuromuscular blocking drugs (See Appendix 3).\n6. Donor has current or history of malignancy.\n7. Donor has current or history of insulin dependent diabetes\n8. Donor has current gestational diabetes treated with insulin, or pre-eclampsia.\n9. Donor is known to be a carrier of a primary mitochondrial disease.","FEMALE","45 Years",{"count":109,"type":21},300,"Placenta will be collected and from these, mitochondrial will be harvested. Mitochondria will be used in mitochondrial augmentation therapy.",[112],"Pregnancy Related",{"date":94,"type":37},{"date":115,"type":37},"2018-12-01",{"date":117,"type":21},"2028-03",{"name":43,"class":44},""]