[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sci\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sci":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100649836","early-phase-1-neurorise-intrathecal-ce-1-treatment-for-traumatic-sci-100649836",false,"NCT07739043","NeuroRise: Intrathecal CE-1 Treatment for Traumatic SCI","A Single-Arm and Open Labeled Clinical Study of CE1 (Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells, or UC-MSC) in Traumatic Spinal Cord Injury Patients Within Ten Years of Injury","NeuroRise","Inclusion Criteria:\n\n1. Once the voluntary nature of the study is explained in detail, the participant must be willing to provide written informed consent and complete HIPAA documentation before conducting any study-related procedure. A signed written informed consent and ability to comply with the study protocol according to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and local regulations is required.\n2. Male or female aged 18 years and older at the time of enrollment\n3. Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal\u002Fbarrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than two years. If the urine pregnancy test is positive, the study drug will not be administered, and the result will be confirmed by a serum β-hCG test. β-hCG tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using a kit.\n4. Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcomes. Any serious adverse events (SAE) associated with pregnancy will be recorded.\n5. SCI categorized as either complete (AIS grade A) or incomplete (AIS grade B, C or D) at the time of recruitment.\n6. Injuries located below the C2 level confirmed by MR imaging.\n7. SCI must be traumatic, blunt\u002Fnon-penetrating in nature, and not degenerative.\n8. Full understanding of the requirements of the study and willingness to comply with the treatment plan, laboratory tests, diagnostic imaging, complete physical and neurologic examination, and follow-up visits and assessments.\n9. Full understanding of the requirements of their rehabilitation program prescribed by physical and occupational therapists.\n10. Injury within 10 years before enrollment or screening period. Both acute and chronic SCI patients may be enrolled. Chronic SCI is defined as at least one year post-injury with stabilized neurological function.\n11. The participant must be able to tolerate intrathecal injections.\n12. The participant must have negative serology for HIV, VDRL, Hepatitis B and C\n13. Adequate vital organ function defined by normal laboratory values for creatinine, ALT, AST, total bilirubin, NT-ProBNP. If these labs are out of range, they must be reviewed by PI and confirmed. Rescreening can be done after treatment and retesting.\n14. Blood platelets count equal to or higher than 100,000 \u002FμL and INR level equal to or less than 1.5 must be encountered.\n\nExclusion Criteria:\n\n1. Pregnant or nursing, or planning on becoming pregnant during the study period\n2. SCI initially classified as AIS grade E at the time of injury\n3. SCI located above C2 level confirmed by magnetic resonance imaging (MRI).\n4. History of receiving MSC, gene or exosome therapy for any indications\n5. History of intra-spinal infection\n6. History of superficial infection in the index spinal level within 6 months of enrollment\n7. Evidence of current superficial infection affecting the index spinal level at the time of enrollment\n8. On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including chronic use of systemic steroids\u002Fcorticosteroids. Use of steroids\u002Fcorticosteroids in the acute SCI phase is permissible but the participant must have been off steroids for at least 14 days prior to the first injection and cannot take steroids for at least one month after injection.\n9. Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.\n10. Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis.\n11. Fever, defined as temperature above 99ºF\u002F37.2ºC or mental confusion at the time of IPA.\n12. Clinically significant cardiovascular (e.g., history of myocardial infarction, congestive heart failure or uncontrolled hypertension \\> 90 mmHg diastolic and\u002For 180 mmHg systolic), neurological (e.g., stroke, TIA) renal, hepatic or endocrine disease (e.g., diabetes, osteoporosis).\n13. History of malignancy including melanoma except for localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline). Any other malignancy will not be allowed. Provided they have not demonstrated clinical signs or symptoms of infection and have not required treatment, participants with large granular lymphocytic leukemia, upon consultation with their Hematologist\u002FOncologist, may be considered but should undergo additional testing at screening.\n14. History of blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy.\n15. History of bleeding disorders and actual levels of blood platelet lower than 100,000\u002FμL and\u002For INR equal to or higher than 1.5.\n16. History or presence of brain injury, hydrocephalus, meningitis, cerebral palsy, altered consciousness, signs\u002Fsymptoms of neurodegenerative disorders (e.g., stroke, amyotrophic lateral sclerosis, multiple sclerosis, etc.), based on medical history and at the discretion of the investigator.\n17. Participation in a study of an experimental drug or medical device within 3 months of study enrollment\n18. Known allergy to local anesthetics of other components of the study drug.\n19. Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures.\n20. History of or current evidence of alcohol or drug abuse or dependence, recreational use of an illicit drug or prescription medications, or use of medical marijuana within 28 days of study entry\n21. Diagnosis of schizophrenia or bipolar disorder\n22. Participants with untreated baseline depression, diagnosed by the Beck Depression Inventory, past medical history, and baseline assessment conducted by a psychologist or a psychiatrist. Participants with depression or anxiety disorders who are in remission or receiving treatment can be enrolled in the study.\n23. Any severe condition pre-existing before or after traumatic SCI at the discretion of the Principal Investigator (PI).","ALL","18 Years",{"count":20,"type":21},8,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The purpose of this study is to assess the safety and tolerability of intrathecal administration of CE-1 at a weight-based dose (cells\u002Fkg BW), capped at a maximum total dose of 1×10⁸ cells in 10 mL, with administered volume calculated using M = 0.167 mL\u002Fkg BW.\n\nStudy details include:\n\nThe overall study duration will be up to three years. The primary endpoint will be assessed at 6 months following investigational product administration. An additional secondary endpoint will be assessed at 12 months in the form of a phone call.\n\nStudy visits therefore consist of one interventional visit, an evaluation visit within two weeks post-injection, a primary endpoint follow-up visit at 6 months, and a secondary endpoint follow-up phone call at 12-months.",[27,28,29],"SCI - Spinal Cord Injury","SCI","Spinal Cord Injury",[31,32,33],"Stem cells","Spinal cord injury","Mesenchymal stem cells","NOT_YET_RECRUITING","2026-07-28",{"date":37,"type":38},"2026-07-31","ACTUAL",{"date":40,"type":21},"2026-09",{"date":42,"type":21},"2027-09",{"name":44,"class":45},"Cell Therapy LLC","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":5},"100611001","arc-im-therapy-to-support-and-promote-recovery-of-ambulatory-functions-in-people-with-subacute-and-chronic-spinal-cord-injury-100611001","NCT07234903","ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury","EIGER","Inclusion Criteria:\n\n1. Must be at least 18 years old and no older than 65 years old at the time of enrollment.\n2. Must be graded A, B, C, or D in the ASIA Impairment Scale (AIS).\n3. Must have a SCI level at T10 or higher as determined by ISNCSCI, with the region extending 6 cm above the tip of the conus remaining anatomically intact as determined by MRI.\n4. Must have sustained their injury either less than 6 weeks prior to baseline (Group \"Subacute SCI\"), or more than 1 year prior to enrollment (Group \"Chronic SCI\").\n5. Must be suffering from a SCI due to trauma.\n6. Must have a stable medical, physical and psychological condition as considered by the investigators and the delegated specialists.\n7. Must have residual upper limb function to use the arms for weight bearing support (as determined by functional demonstration).\n8. Must be able to understand and interact with the study team in German, French or English.\n9. Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments.\n10. Must provide Informed Consent as documented by signature prior to any study-related procedures.\n11. Must have an acceptable or highly effective method of contraception for women of childbearing capacity.\n\nExclusion Criteria:\n\n1. Must not be pregnant nor breastfeeding.\n2. Must not have brain damage.\n3. Must not have a history of epilepsy\n4. Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study.\n5. Must not have previously been injected with stem cells in the spinal cord.\n6. Must not have any diseases and conditions that would increase the morbidity and mortality of SCI surgery.\n7. Must not require ventilator support.\n8. Must not have any existing contraindication to mobility functions (e.g., unhealed bone fractures, central nervous system disorder, peripheral nerve disorder, etc.).\n9. Must not suffer from SCI from other etiology than trauma (ischemic, tumoral, autoimmune, etc.).\n10. Must not have any anatomical limitations in the implantation area as judged by the investigators (e.g., spinal stenosis, limiting protrusions, post-traumatic bone damage at area of implantation).\n11. Must not require the use of an intrathecal baclofen pump.\n12. Must not have any active implanted devices.\n13. Must not have any other conditions that would make the subject unable to participate in testing in the judgment of the investigators (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.).\n14. Must not be the investigator him\u002Fherself, his\u002Fher family members, employees or other dependent persons.","65 Years",{"count":56,"type":21},12,[58],"NA","The EIGER study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to support and promote recovery of ambulatory functions, such as walking, in people with subacute and chronic spinal cord injury.",[29,28,27,61,62,63],"Subacute Spinal Cord Injury","Chronic Spinal Cord Injury","Spinal Cord Injury (SCI)",[28,29,65,66,67],"Epidural Electrical Stimulation","Spinal Cord Stimulation","ARC-IM Therapy","RECRUITING","2026-04-16",{"date":71,"type":38},"2026-04-21",{"date":73,"type":21},"2026-04",{"date":75,"type":21},"2032-04",{"name":77,"class":45},"Ecole Polytechnique Fédérale de Lausanne"]