[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-sclerosis-primary-progressive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-sclerosis-primary-progressive":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,54,83,111,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":36,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100466892","phase-1-assessing-changes-in-multi-parametric-mri-in-ms-patients-taking-clemastine-fumarate-as-a-myelin-repair-therapy-100466892",false,"NCT05359653","Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy","A Randomized, Double-Blind, Delayed Treatment, Placebo-Controlled Trial to Assess the Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy","ReVIVE","Inclusion Criteria:\n\n* Written informed consent must be obtained prior to any assessment being performed.\n* Patients diagnosed with relapsing remitting multiple sclerosis and a disease duration of \\\u003C 15 years\n* Male or female patients aged 18-55 years (inclusive)\n* Use of appropriate contraception during period of trial (women). Before entry women must be:\n\n  * Post-menopausal for at least 1 year OR\n  * Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, male partner vasectomy or otherwise incapable of pregnancy) OR\n  * Practicing a highly effective method of birth control if sexually active, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g., condoms, diaphragm or cervical cap with spermicidal foam, cream or gel), or male partner sterilization consistent with local regulations regarding use of birth control methods for patients participating in clinical trials, for the duration of their participation in the study OR\n  * Not heterosexually active (patients who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study) OR\n  * Practicing true abstinence (when this is in line with the preferred and usual lifestyle of the subject) Period abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) is not an acceptable method.\n\nExclusion Criteria:\n\n* Radiologic identification of marked brain atrophy relative to patients age based on recent MRI and interpretation of expert neuroradiologist or PI\n* New lesion in most recent MRI (within 3 months)\n* Hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients.\n* Treatment with corticosteroids within 30 days prior to screening.\n* Expanded Disability Status Scale (EDSS) ≥ 4.5\n* History of significant cardiac conduction block.\n* History of cancer.\n* Suicidal ideation or behavior in 6 months prior to baseline.\n* Pregnancy, breastfeeding or planning to become pregnant.\n* Involved with other study protocols simultaneously without prior approval.\n* Concomitant use of any other putative remyelinating therapy as determined by the investigator.\n* Prior treatment with total lymphoid irradiation, T cell or T cell receptor vaccination.\n* Prior treatment with alemtuzumab, mitoxantrone, or cyclophosphamide.\n* Serum creatinine \\> 1.5 mg\u002FdL; aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase \\> 2 times the upper limit of normal. (Reported within 72 hours)\n* History of drug or alcohol abuse within the past year.\n* Untreated B12 deficiency (as determined by B12 serological assessments and metabolites including methylmalonic acid \\[MMA\\] and homocysteine) or untreated hypothyroidism.\n* Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases that in the PI's judgment may affect the interpretation of study results or patient safety.\n* History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator would preclude participation in the study\n* Inability to participate in MRI, including extreme claustrophobia.\n* Any dental braces or permanent or undetachable metals in the jaw or face.","ALL","18 Years","55 Years",{"count":21,"type":22},74,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with chronic inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments.\n\nNo reparative therapies exist for the treatment of multiple sclerosis. Clemastine fumarate was identified along with a series of other antimuscarinic medications as a potential remyelinating agent using the micropillar screen (BIMA) developed at the University of California, San Francisco (UCSF). Following in vivo validation, an FDA IND exemption was granted to investigate clemastine for the treatment of multiple sclerosis in the context of chronic optic neuropathy. That pilot study was recently completed and is the first randomized control trial documenting efficacy for a putative remyelinating agent for the treatment of MS. The preselected primary efficacy endpoint (visual evoked potential) was met and a strong trend to benefit was seen for the principal secondary endpoint assessing function (low contrast visual acuity). That trial number was 13-11577.\n\nThis study seeks to follow up on that study and examine clemastine fumarate's protective and reparative effects in the context of chronic demyelinating brain lesions as imaged by multi-parametric MRI assessments. The investigators will be assessing the effects of clemastine fumarate as a remyelinating therapy and assessing its effect on MRI metrics of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis.\n\nIn addition to using conventional multi-parametric MRI assessments, this study will also evaluate a new MRI technique called Ultrashort Echo Time (UTE) MRI to assess the effects of clemastine fumarate as a remyelinating therapy of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis and compare it to the other assessments.",[29,30,31,32,33,34,35],"Multiple Sclerosis (MS)","Multiple Sclerosis, Relapsing-Remitting","Multiple Sclerosis, Primary Progressive","Multiple Sclerosis, Chronic Progressive","Multiple Sclerosis Relapse","Multiple Sclerosis Brain Lesion","Multiple Sclerosis Benign",[37,38,39,40],"multiple sclerosis","mri","brain","spinal cord","RECRUITING","2026-06-30",{"date":44,"type":45},"2026-07-02","ACTUAL",{"date":47,"type":45},"2023-08-01",{"date":49,"type":22},"2027-06-01",{"name":51,"class":52},"University of California, San Francisco","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":53},"100526698","phase-1-a-study-of-anti-cd19-chimeric-antigen-receptor-t-cell--car-t-therapy-in-subjects-with-non-relapsing-and-progressive-forms-of-multiple-sclerosis-100526698","NCT06138132","A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis","A Phase 1, Open-Label, Single Center Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis","Inclusion Criteria:\n\n1. Patient is ≥ 18 years old, and ≤65 years of age, at time of screening visit.\n2. Diagnosis of MS according to the 2017 McDonald Criteria.\n3. Progressive MS by 2014 Lublin MS phenotypic criteria.\n4. Presence of varicella-zoster virus (VZV) antibodies, or completion of at least one dose of the varicella zoster glycoprotein E (gE) Shingrix vaccine at least four weeks prior to treatment.\n5. Presence of anti EBV antibodies.\n6. Organ and Marrow Function\n\n   * Absolute neutrophil count (ANC) ≥ 2000\u002FuL.\n   * Platelet count ≥ 150,000\u002FuL.\n   * Absolute lymphocyte count ≥ 1000\u002FuL.\n   * Serum immunoglobulin G (IgG) ≥ 500mg\u002FdL.\n   * Hemoglobin ≥ 9 g\u002FdL.\n   * Adequate renal, hepatic, pulmonary and cardiac function defined as:\n\n     * Creatinine ≤ 2mg\u002FdL or creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL\u002Fmin.\n     * Serum alanine transaminase (ALT)\u002Faspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN).\n     * Total bilirubin ≤ 1.5 mg\u002Fdl, except in subjects with Gilbert's syndrome\n     * Cardiac ejection fraction ≥ 40%, no evidence of physiologically significant pericardial effusion as determined by an ECHO, and no clinically significant ECG findings.\n     * Baseline oxygen saturation \\> 94% on room air.\n7. Testing for\n\n   * Hepatitis B core antibody (HBc Ab)\n   * Hepatitis C antibody (HCV Ab)\n   * Hepatitis B surface antigen (Hep B surf. AG)\n   * HIV 1\\&2 Ab\n   * Syphilis Screen\n   * Human T-cell lymphotropic virus (HTLV) Ab I \\& II\n   * Nucleic acid test multiplex (NAT MPX) for HIV, HCV, HBV\n   * Herpes Simplex Virus 1 \\& 2 IgG panel\n   * Varicella-Zoster (VZ) IgG\n   * Cytomegalovirus (CMV) Total Ab\n\n   Must be seronegative for HIV-1 RNA polymerase chain reaction (PCR); HIV 1 and HIV 2 Ab (antibody); HTLV-1 and HTLV-2 Ab; PCR+ or negative surface antigen for hepatitis B; negative for the Treponema pallidum antibody Syphilis screen; and negative for HIV-1 and hepatitis C by nucleic acid testing (NAT) within 40 days of apheresis procedures.\n8. Females of childbearing potential have a negative serum or urine pregnancy test because of the potentially dangerous\u002Funknown effects on the fetus. Females who have undergone hysterectomy or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.\n9. Contraception: Subjects of child-bearing or child-fathering potential must be willing to practice highly effective birth control from the time of enrollment on this study and for the entire study period which is 12 months after receiving the CAR T cell infusion.\n10. Ability to understand and the willingness to sign a written informed consent document. Patients must have signed informed consent to participate in the trial.\n11. Adequate vital sign criterion with acceptable numerical ranges of:\n\n    * Systolic Blood Pressure (mmHg) ≥ 100 and ≤ 150\n    * Diastolic Blood pressure (mmHg) ≥ 60 and ≤ 90\n    * To ensure subject safety and stability, any subject who is noted to have a BP \\> 150\u002F90 mm Hg should be stable on anti-hypertensive medications with repeated BP ≤150\u002F90 for at least one month prior to enrollment in the study\n    * Heart Rate ≥ 60 and ≤ 100 bpm\n    * Oral Temperature ≤ 37.7 C\u002Fafebrile\n    * Respiratory rate ≥ 12 and ≤ 20bpm\n\nExclusion Criteria:\n\n1. History of neuromyelitis optica spectrum disorder (NMOSD) or MOG antibody associated disease (MOGAD).\n2. Prior treatment with any investigational agent within 3 months, or 5 half-lives, whichever is longer. Agents authorized by the FDA for prevention or treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are not considered investigational.\n3. Initiation of any DMT between the completion of apheresis and start of lymphodepletion (LD) chemotherapy. The use of methylprednisolone for bridging therapy between apheresis and start of LD chemotherapy will be allowed.\n4. History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis or non-MS progressive neurologic condition affecting ability to perform study assessments.\n5. History of cytopenia consistent with the diagnosis of myelodysplastic syndrome (MDS).\n6. History of sickle cell anemia or other hemoglobinopathy.\n7. Coagulation abnormalities defined by: international normalized ratio (INR) \\> 1.5, prothrombin time (PT) \\> 14 seconds, partial thromboplastin time (PTT) \\> 45 seconds to the exclusion criteria. Patients with positive antiphospholipid antibodies, including anti-cardiolipin, or lupus anticoagulant.\n8. Presence of fungal, bacterial, viral, or other infection that is not controlled and\u002F or requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening. Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.\n9. Psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the Stanford Transplant team caring for this potential patient would place the patient at an unacceptable risk.\n10. Presence or history of liver cirrhosis.\n11. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years\n12. Active infection with HIV, hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) as the immunosuppression contained in this study may pose unacceptable risk. A prior history of hepatitis B or hepatitis C is permitted providing the viral load is undetectable per quantitative PCR and\u002For nucleic acid testing. Hepatitis B surface antibody following hepatitis B immunization is not considered to be evidence of past infection.\n13. Central nervous system (CNS) disorder such as cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease unrelated to MS that in the judgment of the investigator may impair the ability to evaluate neurotoxicity.\n14. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease (uncontrolled congestive heart failure) within 4 months of enrollment. Subjects with stable cardiac disease fulfilling inclusion criteria are allowed.\n15. Subjects receiving anticoagulation therapy or subjects with concomitant use of antiplatelet agents.\n16. History of Crohn's, rheumatoid arthritis, systemic lupus that required continued systemic immunosuppression\u002Fsystemic disease modifying agents within the 2 years prior to trial enrollment.\n17. A primary immune deficiency disease\n18. In the investigator's judgment, the subject is unlikely to complete protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.\n19. History of severe immediate hypersensitivity reaction to any of the agents used in this study. This includes contraindications or life-threatening allergies, hypersensitivity, or intolerance to KYV-101 or its excipients, including dimethyl sulfoxide; Bendamustine; or tocilizumab.\n20. Any medical condition that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of study treatment.\n21. Prior treatment with total lymphoid irradiation or mitoxantrone exceeding 36 mg\u002Fm2 cumulative dose\n22. Prior treatment with autologous hematopoietic stem cell transplantation, or prior history of cellular immunotherapy (eg. CAR T) or gene therapy directed at any target.\n23. Prior treatment with anti-CD20+ monoclonal antibody therapy within 9 months of trial initiation. A 30-day washout will be required for prior treatment with glatiramer acetate, interferon-beta, and fumarates. A 60-day washout will be required for sphingosine-i-phosphate modulators and natalizumab. Excluded will be patients who received prior treatment with mitoxantrone regardless of prior cumulative dose.\n24. Prior history of solid organ transplantation\n25. Impaired cardiac function or clinically significant cardiac disease including:\n\n    * a. Unstable angina or myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to apheresis.\n    * b. New York Heart Association (NYHA) stage III or IV congestive heart failure.\n    * c. History of clinically significant cardiac arrhythmia (eg, ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block.\n    * d. History of severe nonischemic cardiomyopathy.\n    * e. Left ventricular ejection fraction (LVEF) \\\u003C45% as assessed by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan (performed ≤8 weeks of apheresis).\n    * f. Active, current cardiac manifestations of systemic lupus erythematosus (SLE) including pericarditis, pericardial effusion, and myocarditis.\n26. Prior history of splenectomy\n27. History of moderate or worse than moderate asthma or chronic obstructive pulmonary disease (COPD)\n28. Corrected QT interval (QTc) \\>450msec in males or \\>470msecs in females\n29. Subjects with valvular heart disease (regurgitation, stenosis or atresia\n30. Moderate or worse renal impairment using criteria\n\n    * Stage 1: Kidney damage with normal or increased GFR (\\>90 mL\u002Fmin\u002F1.73 m\\^2).\n    * Stage 2: Mild reduction in GFR (60-89 mL\u002Fmin\u002F1.73 m\\^2).\n    * Stage 3a: Moderate reduction in GFR (45-59 mL\u002Fmin\u002F1.73 m\\^2).\n    * Stage 3b: Moderate reduction in GFR (30-44 mL\u002Fmin\u002F1.73 m\\^2).\n    * Stage 4: Severe reduction in GFR (15-29 mL\u002Fmin\u002F1.73 m\\^2).\n    * Stage 5: Kidney failure (GFR \\\u003C 15 mL\u002Fmin\u002F1.73 m\\^2 or dialysis)\n31. Previously received Mavenclad, yet drug washout is ≤9 months.\n32. History of a seizure disorder even if the seizure disorder is well controlled with anti-epileptics\n33. Prior history of treatment with cellular immunotherapy (e.g. CAR T) gene therapy product directed as any target.","65 Years",{"count":63,"type":22},12,[25],"A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy in Subjects with Non-relapsing and Progressive Forms of Multiple Sclerosis",[67,31,68],"Multiple Sclerosis","Multiple Sclerosis, Secondary Progressive",[70,71,72,73],"KYV-101","autoimmune disease","anti-CD19 CAR-T therapy","cellular therapy","2026-02-24",{"date":76,"type":45},"2026-02-27",{"date":78,"type":45},"2024-04-10",{"date":80,"type":22},"2027-06",{"name":82,"class":52},"Stanford University",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":53},"100556535","clinnova-ms-a-prospective-cohort-study-of-patients-with-multiple-sclerosis-switzerland-100556535","NCT06526364","Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis (Switzerland)","Clinnova-MS: a Prospective Cohort Study of Patients With Multiple Sclerosis: A Trans-Regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care (Switzerland)","Inclusion Criteria:\n\n* Age ≥18\n* Participants are willing and able to comply with the protocol, including undergoing data and samples collection as well as study visits and examinations.\n* Signed informed consent form\n* In possession of a Healios+Me app compatible smartphone (iOS\u002FAndroid)\n* Corrected close visual acuity of ≥0.5\n* Hand motor skills sufficient for using a smartphone\n* Ability to follow the study procedures\n* Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms inclusive (clinically isolated syndrome, RRMS, SPMS, PPMS) AND early disease stages (\\\u003C 3 years) OR transitioning phase to progressive disease as evaluated based on Expanded Disability Status Scale (EDSS).\n* Enrolled in the SMSC at University Hospital Basel\n\nThere are no specific exclusion criteria.",{"count":91,"type":22},100,"OBSERVATIONAL","This prospective cohort study is part of the Clinnova programme and aims to (i) identify clinical imaging and omics characteristics associated with early Multiple Sclerosis (MS) and with transitioning phases to progressive MS, as well as (ii) to investigate digital biomarkers allowing the continuous clinical monitoring of those patients.",[67,30,31,68],[96,97,98,99,100,101],"Immune-meditated Diseases","Artificial Intelligence","Personalized medicine","Treatment change","Phenotyping","Clinnova","2025-12-18",{"date":104,"type":45},"2025-12-26",{"date":106,"type":45},"2024-12-10",{"date":108,"type":22},"2029-06",{"name":110,"class":52},"University Hospital, Basel, Switzerland",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":4},"100585271","phase-1-a-study-of-allogeneic-hematopoietic-cell-transplantation-for-primary-progressive-multiple-sclerosis-100585271","NCT06900192","A Study of Allogeneic Hematopoietic Cell Transplantation for Primary Progressive Multiple Sclerosis","A Multicenter Phase 1 Study of Allogeneic Hematopoietic Cell Transplantation for Primary Progressive Multiple Sclerosis Using Orca-Q, an Engineered Donor Graft Derived From Mobilized Peripheral Blood","Inclusion Criteria (Recipient):\n\n1. Participants aged ≥18 and ≤65 years with primary progressive multiple sclerosis\n2. A diagnosis of PPMS by 2017 McDonald criteria and 2013 clinical course revision102\n3. CSF with elevated IgG index or 2 or more oligoclonal bands\n4. EDSS (see Appendix 9) between 2.0 and 5.5 inclusive\n5. Based on review of the clinical records, there must be a deterioration in the EDSS of at least 1 or more points over the previous 4 years (or less).\n6. Eligibility criteria confirmed by the Eligibility Review Group (Appendix 10)\n7. Recipients who have been treated with ocrelizumab, rituximab, ofatumumab, ublituximab, or alemtuzumab must undergo a washout period as described in Appendix 14 prior to their planned day 0.\n8. Recipients must be willing to undergo mobilized autologous peripheral blood stem cell collection to create a cryopreserved rescue product prior to alloHCT.\n9. Ability to undergo MRI without general anesthesia\n10. Ability to undergo all tests and procedures in the study\n11. Patients who are not vaccinated for COVID-19 must have no symptoms of COVID-19 and have negative testing for COVID-19. For other vaccine-preventable illnesses, it is recommended that patients are current on their vaccination schedule.\n\nExclusion Criteria:\n\n1. History of Progressive Multifocal Leukoencephalopathy\n2. Organ dysfunction or disease that would jeopardize survival after hematopoietic cell transplantation, including but not limited to the following:\n\n   1. Renal insufficiency as defined by an estimated GFR \\\u003C60 mL\u002Fminute\n   2. Cardiac dysfunction as defined by symptomatic coronary artery disease, congestive heart failure, valvular heart disease, cardiomyopathy, uncontrolled arrhythmia(s), or left ventricular ejection fraction \\\u003C50%. Participants with a history of these conditions may enroll if they are demonstrated to have optimal cardiac function (as defined by echocardiography or multi-gated acquisition scan)\n   3. Pulmonary dysfunction that poses a risk of mortality after transplant, defined as pre-transplant pulmonary function testing demonstrating a FEV1 \\\u003C70% expected and\u002For a DLCOadj \\\u003C70% expected.\n   4. Necroinflammatory or fibrotic liver disease with evidence of liver dysfunction, including but not limited to jaundice, hepatic encephalopathy, or portal hypertension\n   5. Marrow dysfunction that poses a risk of peri-transplant mortality, defined as an absolute neutrophil count (\\\u003C1000\u002Fmm3) below the lower limit of normal, or a platelet count below 50,000\u002Fmm3.\n   6. Poorly controlled hypertension despite appropriate therapy, defined as a diastolic blood pressure greater than 90 mm Hg while on therapy.\n   7. Poorly controlled diabetes mellitus, defined as HgbA1c ≥ 6.5% despite therapy or recurrent hypoglycemia while on therapy.\n   8. Extreme protein-calorie malnutrition defined by Body Mass Index \\\u003C18 and unintentional weight loss (3 kg in the last month or 6 kg in the last 6 months.)\n3. History of smoking either tobacco or other herbal products in the last 3 months.\n4. Planned pharmaceutical in vivo or ex vivo T cell depletion (TCD), eg, cladribine, or peritransplant antithymocyte globulin (ATG). For participants who have previously been exposed to a TCD agent, a 5-half-life washout of the agent must occur prior to planned day 0 (day 0 is defined as the day of infusion Orca-Q Prime). The washout period for alemtuzumab is listed in Appendix 14.\n5. HIV seropositive.\n6. HBV serology results indicating chronic HBV infection per https:\u002F\u002Fwww.cdc.gov\u002Fhepatitis\u002Fhbv\u002FinterpretationOfHepBSerologicResults.htm, unless HBV PCR negative. HBV seropositive participants should be on antiviral therapy after transplant.\n7. HCV seropositive, unless PCR negative and having undergone 'curative' antiviral therapy.\n8. Participant has active uncontrolled infection\n9. Participant has demonstrated lack of compliance with prior medical care\n10. Participants with known active malignancy. It is recommended that patients are current on cancer screening tests for their age and family history as per the NCCN \\[The National Comprehensive Cancer Network®\\] Guidelines. Screening should be performed, if indicated, per NCCN guidelines prior to study treatment.\n11. Participants whose life expectancy is severely limited by illness other than multiple sclerosis\n12. Females who are pregnant or breast feeding.\n13. Medical or psychiatric conditions that compromise ability to give informed consent or to comply with treatment protocol\n14. Inability to undergo an MRI scan\n15. Currently receiving treatment with investigational agents\n16. Positive for JC virus DNA in the CSF or blood during screening.",{"count":119,"type":22},10,[25],"A study of alloHCT with Orca-Q for the treatment of primary progressive multiple sclerosis (MS).",[123,67,31,68],"Primary Progressive Multiple Sclerosis","NOT_YET_RECRUITING","2025-03-26",{"date":127,"type":45},"2025-03-28",{"date":129,"type":22},"2025-03",{"date":131,"type":22},"2029-08",{"name":82,"class":52},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":141,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":144,"conditions":145,"keywords":153,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":53},"100454970","ms-researchbiomarkers-100454970","NCT05204459","MS-ResearchBiomarkerS","Investigating the Longitudinal Relationships Between Visual Pathway Injury, Radiological and Blood Biomarkers in Multiple Sclerosis and Related Disorders","MS-ReBS","Inclusion Criteria:\n\n* Subjects who meet any one of the following diagnostic criteria:\n\n  * Diagnosis of MS, CIS,or RIS based on the 2017 revised McDonald criteria.\n  * Diagnosis of NMOSD based on the 2015 revised NMOSD consensus diagnostic criteria.\n  * Diagnosis of myelin oligodendrocyte glycoprotein (MOG)-related encephalomyelitis, optic neuritis, or other associated disease.\n  * Diagnosis of neurological disorders other than MSRD.\n  * Healthy volunteer.\n* Age ≥18.\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* Patients will be excluded from the MRI portions of the study if they have a contraindication to MRI(metallic implantsor foreign bodies, claustrophobia, MRI-incompatible pacemakers, MRI- incompatible prosthetic heart valves).\n* Patients will be excluded from the MRI portions of the study if they are pregnant, but their demographic, clinical information,and disability measures may still be captured under the study.\n* Patients will be excluded from the visual assessment portions of the study if they have had any recent ocular surgery (within the past two months), refractive errors of greater than or equal to ±6 diopters or other eye diseases that may affect or confound OCT\u002FOCTA measurements (ex., age-related macular degeneration, advanced geographic atrophy, diabetic retinopathy, glaucoma).",true,{"count":143,"type":22},1000,"This study is being conducted to investigate risk factors for disability progression in Multiple Sclerosis and related disorders (MSRD). The primary goal is to assess whether combining information from visual assessment, blood markers, as well as historical and ongoing longitudinal MRIs of the brain, orbit (the part of the skull where eyes are located), and\u002For spinal cord can predict changes in quantitative disability measures related to MSRD and neurological disease.",[67,30,31,68,146,147,148,149,150,151,152],"Clinically Isolated Syndrome","Radiologically Isolated Syndrome","Neuromyelitis Optica Spectrum Disorders","Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease","Neurologic Autoimmune Disease","Neurologic Disorder","Healthy Aging",[67,30,31,68,146,147,148,154,150,151,152],"Myelin oligodendrocyte glycoprotein antibody-associated disease","2024-02-05",{"date":157,"type":45},"2024-02-06",{"date":159,"type":45},"2021-11-11",{"date":161,"type":22},"2041-11-11",{"name":163,"class":52},"Cedars-Sinai Medical Center"]