[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-spinal-cord-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-spinal-cord-injury":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100611001","arc-im-therapy-to-support-and-promote-recovery-of-ambulatory-functions-in-people-with-subacute-and-chronic-spinal-cord-injury-100611001",false,"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.","ALL","18 Years","65 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32],"Spinal Cord Injury","SCI","SCI - Spinal Cord Injury","Subacute Spinal Cord Injury","Chronic Spinal Cord Injury","Spinal Cord Injury (SCI)",[28,27,34,35,36],"Epidural Electrical Stimulation","Spinal Cord Stimulation","ARC-IM Therapy","RECRUITING","2026-04-16",{"date":40,"type":41},"2026-04-21","ACTUAL",{"date":43,"type":21},"2026-04",{"date":45,"type":21},"2032-04",{"name":47,"class":48},"Ecole Polytechnique Fédérale de Lausanne","OTHER",2,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100488750","restores-trial-restoration-of-rehabilitative-function-with-epidural-spinal-stimulation-100488750","NCT05644171","RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation","RS-01","⦁ Inclusion Criteria\n\nFor inclusion in the study, the potential patient has to fulfil all of the following criteria:\n\n1. 21 years old and older\n2. Chronic (greater than one year) motor complete (AIS classification A or B) SCI\n3. Spinal injury between the levels of Cervical 2 (C2) to Thoracic 12 (T12)\n4. Segmental reflexes that remain functional below the level of lesion\n5. Able to perform the perioperative rehabilitation program as judged by the research team\n\n   * Exclusion Criteria\n\nPotential patients will be excluded from the trial if they fulfil any of the following criteria:\n\n1. Significant medical co-morbidities that would significantly increase the risk of the operation\n2. Severe dysautonomia with systolic blood pressure fluctuation less than 50 or more than 200mmHg on tilt table testing\n3. Painful musculoskeletal dysfunction, contractures, unhealed fractures, pressure sores, severe spasticity, and osteoporosis\n4. Significant psychological issues or ongoing drug abuse\n5. Pregnancy and lactating patients\n6. Progressive spinal cord disease","21 Years",{"count":59,"type":21},18,[24],"Spinal Cord Injury (SCI), being a devastating diagnosis, has little to no recovery which leads to a long-standing of debilitating impairment for affected patients. The NNI Neurosurgery team, together with our collaborators, are expanding our recruitment from our pilot trial named RESTORES: RESToration of Rehabilitative function with Epidural Spinal Stimulation. This study aims to investigate the feasibility of electrical stimulation via a spinal cord stimulator (SCS), which will be implanted into the study subjects, and advanced robotic neurorehabilitation to aid in improving neurological function in patients diagnosed with chronic SCI. An additional 15 patients on top of the 3 ongoing patients, male and female participants, above the age of 21 who have been diagnosed with the condition for more than a year will be recruited for this study over a 2-year period. Rehab sessions will take place pre and post-surgical implant, assessing subject improvements",[31],[64,65,66],"Spinal cord injury","Epidural spinal stimulation","Implantation","2026-01-23",{"date":69,"type":41},"2026-01-26",{"date":71,"type":41},"2022-12-19",{"date":73,"type":21},"2031-12-30",{"name":75,"class":48},"National Neuroscience Institute",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":76},"100587015","phase-1-first-in-human-clinical-trial-of-stup-001-an-in-vivo-direct-cell-conversion-gene-therapy-for-ais-ab-chronic-spinal-cord-injury-100587015","NCT06922890","First-in-Human Clinical Trial of STUP-001, an In Vivo Direct Cell Conversion Gene Therapy for AIS-A\u002FB Chronic Spinal Cord Injury","A Single-center, Prospective Investigator-initiated Trial to Evaluate the Safety and Exploratory Efficacy of STUP-001 in Patients With Chronic Spinal Cord Injury of AIS-A or B Level","STUP-001","Inclusion Criteria:\n\n* Male and female adults aged 19 to 60 years at the time of obtaining informed consent.\n* Patients diagnosed with traumatic spinal cord injury classified as ASIA Impairment Scale (AIS) grade A or B:\n\n  1. AIS-A: Complete loss of sensory and motor function.\n  2. AIS-B: Partial preservation of sensory function with complete motor paralysis\n* Patients who have been diagnosed with traumatic spinal cord injury for at least 6 months at the time of screening.\n\nAt the time of screening, women must provide evidence of non-fertile status by meeting at least one of the following criteria:\n\n(a) Postmenopausal women: Defined as women over the age of 50 who have been amenorrheic for at least 12 consecutive months after discontinuing all exogenous hormonal treatments.\n\n(b) Women with irreversible surgical infertility, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. (Tubal ligation is not accepted.) (c) Women 50 years or younger who have been amenorrheic for at least 12 consecutive months after discontinuing all exogenous hormonal treatments and have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the postmenopausal range defined by the study site.\n\n* Acceptable methods of contraception include:\n\n  1. Complete abstinence.\n  2. Tubal sterilization.\n  3. Hormonal contraceptives with no known drug interactions (e.g., levonorgestrel intrauterine system (IUS) (Mirena), medroxyprogesterone).\n  4. Copper intrauterine device (IUD).\n  5. Partner vasectomy. (Note: Periodic abstinence methods (e.g., ovulation timing, symptothermal method, or post-ovulatory methods) and withdrawal are NOT considered acceptable contraception methods.)\n* Individuals who are able to understand the provided information and can voluntarily sign the written informed consent (or have a legally authorized representative sign on their behalf).\n\nExclusion Criteria:\n\n* Patients diagnosed with traumatic spinal cord injury (SCI) classified as AIS-C or D at the time of screening.\n* Patients with the following cardiovascular conditions at the time of screening:\n\n  1. Myocardial infarction or unstable angina within the past 6 months.\n  2. QTc interval ≥ 450 msec or clinically significant electrocardiographic (ECG) abnormalities.\n  3. Congestive heart failure (CHF) classified as New York Heart Association (NYHA) Class II or higher.\n  4. Stroke or transient ischemic attack (TIA) within the past 6 months.\n* Patients with uncontrolled diabetes mellitus (e.g., HbA1c \\> 8% at screening).\n* Patients with uncontrolled hypertension (e.g., systolic BP \\> 180 mmHg or diastolic BP \\> 100 mmHg).\n* Patients diagnosed with, undergoing treatment for, or with a history of malignancy within the past 5 years at the time of screening.\n* Patients with positive serologic test results for HBsAg, anti-HCV Ab, or anti-HIV Ab at the time of screening. However, patients with positive anti-HCV Ab may be eligible if HCV RNA test results are negative after treatment.\n* Patients with clinically significant severe infections, as determined by the investigator (e.g., infections requiring continuous concomitant medication for ≥3 weeks during the clinical trial period).\n* Patients with a history of hypersensitivity to any component of the investigational drug.\n* Patients with a history of gene or cell therapy involving AAV2.\n* Patients with the following abnormal laboratory test results at screening:\n\n  1. WBC \\\u003C 2,000\u002Fmm³\n  2. Platelet count \\\u003C 100,000\u002Fmm³\n  3. Hemoglobin \\\u003C 10.0 g\u002FdL\n  4. Serum creatinine \\> 1.5×ULN\n  5. Total bilirubin \\> 1.5×ULN\n  6. AST, ALT \\> 3×ULN\n  7. PT-INR\u002FaPTT \\> 1.5×ULN\n* Patients with substance abuse, alcohol dependence, or psychiatric disorders.\n* Patients who are unable to undergo general anesthesia.\n* Pregnant or breastfeeding women, or those with a positive pregnancy test at screening.\n* Patients who have received another investigational drug within 4 weeks prior to screening. However, patients who have not received an investigational drug or participated in non-interventional observational studies may be eligible.\n* Any other individuals deemed ineligible for the clinical trial at the investigator's discretion.","19 Years","60 Years",{"count":88,"type":21},9,[90,91],"PHASE1","PHASE2","This study aim to investigate the safety and exploratory efficacy of STUP-001 which is AAV-based spinal cord injury investigational product.",[27,31],[95,96,97],"Direct Lineage Reprogramming","Cell Fate Conversion","First-in-Human Multi-Cistronic Vector Application","2025-07-10",{"date":100,"type":41},"2025-07-16",{"date":102,"type":21},"2025-07-30",{"date":104,"type":21},"2027-12-31",{"name":106,"class":48},"Yonsei University"]