[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"traumatic-spinal-cord-injuries\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:traumatic-spinal-cord-injuries":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100628719","phase-2-treating-spinal-cord-injury-with-early-normobaric-hyperoxia-100628719",false,"NCT07465302","Treating Spinal Cord Injury With Early Normobaric Hyperoxia","Treating Spinal Cord Injury With Early Normobaric Hyperoxia - A Phase IIa Feasibility Trial","SpiCoH","Inclusion Criteria:\n\n1. Provision of signed and dated ICF by the subject or LAR\n2. Stated willingness to comply with all study procedures for the duration of the study\n3. Male or female subjects, aged ≥18 and ≤ 85 years\n4. Admitted with a diagnosis of blunt or penetrating traumatic cervical and\u002For thoracic SCI (maintaining dural sac integrity)\n5. Awake and able to interact and follow commands\n6. American Spinal Injury Association (ASIA) Impairment Scale (AIS) grades A, B or C\n7. Need for mechanical ventilation (MV), as determined by the treating physician\n8. Baseline PaO2 \\>80 mmHg before enrollment\n9. Capacity to initiate the study intervention within 24 hours of injury\n\nExclusion Criteria:\n\n1. Evidence of traumatic brain injury by neuroimaging (either CT or MRI) including, but not limited to, traumatic subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intracranial hemorrhage, parenchymal contusions, and blunt cerebrovascular injury grades II-V\n2. AIS grades D or E at time of arrival to hospital\n3. Persistent hypoxia requiring \\>40% FiO2 to maintain PaO2 \\>80 mmHg\n4. Concurrent injuries contraindicating lumbar drain placement, including, but not limited to: signs of infection at insertion site, elevated intracranial pressure, supratentorial mass lesion with mass effect, posterior fossa mass or uncorrected coagulopathy (thrombocytopenia \\\u003C100,000\u002FμL or International Normalized Ratio \\>1.5)\n5. Pre-existing neurologic conditions that would confound neurologic assessment or would make difficult to accurately assess neurologic and\u002For functional outcomes\n6. Pre-existing respiratory or pulmonary conditions that would impact ventilation mechanics or confound the assessment of respiratory recovery\n7. Participation in a concurrent investigational\u002Finterventional study (observational studies allowed)\n8. Known to be pregnant, or with a positive pregnancy test\n9. Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)\n10. Patient has any other clinically significant medical condition as determined by the investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results","ALL","18 Years","85 Years",{"count":21,"type":22},12,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","SpiCoH is a phase IIa, single center, open-label, clinical trial of intermittent normobaric hyperoxia in mechanically ventilated patients with traumatic cervical and\u002For thoracic spinal cord injury.",[28],"Traumatic Spinal Cord Injuries",[30,31,32,33,34],"normobaric hyperoxia","hyperoxia","biomarkers","traumatic spinal cord injury","FiO2 100%","RECRUITING","2026-04-30",{"date":38,"type":39},"2026-05-01","ACTUAL",{"date":41,"type":39},"2026-04-15",{"date":43,"type":22},"2028-09-30",{"name":45,"class":46},"University of Florida","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":47},"100591508","phase-1-guttmann-neurorecovery---viability-safety-and-efficacy-of-intrathecal-whartons-jelly-mesenchymal-stem-cells-and-transcutaneous-spinal-cord-stimulation-in-chronic-spinal-cord-injury-rehabilitation-100591508","NCT06981338","Guttmann NeuroRecovery - Viability, Safety, and Efficacy of Intrathecal Wharton's Jelly Mesenchymal Stem Cells and Transcutaneous Spinal Cord Stimulation in Chronic Spinal Cord Injury Rehabilitation","Guttmann NeuroRecovery - Viability, Safety, and Efficacy of Intrathecal Wharton's Jelly Mesenchymal Stem Cells and Transcutaneous Spinal Cord Stimulation in Chronic Spinal Cord Injury Rehabilitation: A Pilot Study","GNR-SCI-01","Inclusion Criteria:\n\n* Individuals aged 16-70 years (parental consent required for 16-18-year-olds)\n* Single traumatic spinal cord injury (AIS A-C) at C1-T12 levels\n* Chronic injury (1-5 years post-injury)\n* Stable medical condition with life expectancy \\>2 years\n* Ability to attend follow-up visits and comply with all study procedures\n* Written informed consent (and parental consent for minors)\n* Sufficient cognitive capacity to understand the study\n* For women of childbearing potential: use of effective contraception (hormonal, intrauterine device, barrier methods, sterilization, or post-menopausal status \\>1 year)\n\nExclusion Criteria:\n\n* Severe comorbidities (e.g., cardiovascular instability, active infections)\n* Individuals requiring mechanical ventilation\n* Contraindications for tSCS (e.g., implanted devices)\n* Pregnancy or breastfeeding\n* Neurodegenerative diseases\n* Significant haematological\u002Fbiochemical abnormalities\n* Active or recent (≤5 years) malignancy without complete remission\n* Positive serology for HIV, hepatitis B virus, hepatitis C virus, or syphilis\n* Communication barriers (language, aphasia)\n* Concurrent participation in another clinical trial (within 30 days)\n* Recent intrathecal medication or immunosuppressants (within 60 days)\n* Multi-level spinal lesions or lesions \\>3 spinal segments on MRI\n* Contraindications for lumbar puncture\n* Planned spinal surgery within 24 months\n* Inability to participate in rehabilitation\n* Known allergies to stem cell preparation components","16 Years","70 Years",{"count":59,"type":22},10,[61,25],"PHASE1","This clinical trial primarily aims to evaluate the safety and feasibility of a combined therapeutic approach for chronic spinal cord injury (SCI). The study will investigate whether the combination of intrathecal Wharton's jelly mesenchymal stem cells and transcutaneous spinal cord stimulation (tSCS) is safe and viable in individuals with chronic traumatic SCI.\n\nThe trial will enrol 10 participants aged 16-70 with traumatic SCI (cervical or thoracic levels C1-T12) classified as ASIA Impairment Scale A-C, who are 1-5 years post-injury. Participants will receive three intrathecal injections of Wharton's jelly mesenchymal stem cells, each containing 30 million viable cells (±30%), administered intrathecally at the L3-L4 level. This cellular therapy will be combined with transcutaneous spinal cord stimulation and intensive neurorehabilitation.\n\nParticipants will undergo comprehensive assessments over a 12-month follow-up period to monitor safety, feasibility, and secondarily to evaluate potential improvements in motor, sensory, and autonomic functions. Additional annual follow-up will continue for 2 years after study completion to evaluate long-term safety.",[64,65,28,66],"Spinal Cord Injuries (SCI)","Spinal Cord Injury","Spinal Cord Disease",[68,69,70,71,72,73,74,75,76,77],"Mesenchymal Stem Cells","Spinal Cord Injuries","Cell- and Tissue-Based Therapy","Intrathecal Administration","Neuroplasticity","Spinal Cord Stimulation","Safety","Clinical Trials, Phase I","Electric Stimulation Therapy","Feasibility Study","NOT_YET_RECRUITING","2025-05-21",{"date":81,"type":39},"2025-05-25",{"date":83,"type":22},"2025-09-01",{"date":85,"type":22},"2028-12-31",{"name":87,"class":46},"Institut Guttmann"]