[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spinal-cord-injury-at-c5-c7-level-with-complete-lesion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spinal-cord-injury-at-c5-c7-level-with-complete-lesion":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100234426","multi-functional-neuroprosthetic-system-for-restoration-of-motor-function-in-spinal-cord-injury-100234426",false,"NCT02329652","Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury","NNP-UE+T","Inclusion Criteria:\n\n* Diagnosis of cervical level spinal cord injury, either complete or incomplete; International Standards for Neurological Classification of Spinal Cord Injury (INCSCI) motor level of C4 through C8; American Spinal Injury Impairment Scale (AIS) grade A, B, C, or D; six months or more post-injury\n* Biceps\u002Fbrachialis\u002Fbrachioradialis strength of 2\u002F5 or higher on Manual Muscle Test\n* Peripheral nerve innervation to upper extremity and trunk muscles, including a grade 3\u002F5 or higher stimulated strength (Manual Muscle Test) in at least two of the following muscles in one arm: adductor pollicis, abductor pollicis brevis, flexor pollicis longus, extensor pollicis longus, extensor digitorum communis, flexor digitorum superficialis, flexor digitorum profundus, pronator quadratus, extensor carpi ulnaris, extensor carpi radialis brevis, extensor radialis longus, flexor carpi ulnaris, flexor carpi radialis, first dorsal interosseous; and in at least two of the following muscles: left\u002Fright gluteus maximus, left\u002Fright erector spinae, left\u002Fright quadratus lumborum,\n* Age \\> 16 years\n* Medically stable - cleared for surgery\n* Able and willing to take part in study\n\nExclusion Criteria:\n\n* Currently pregnant (neuroprosthesis implantation delayed until no longer pregnant)\n* Other neurological conditions (multiple sclerosis, diabetes with peripheral nerve involvement)\n* History of coagulopathy, HIV, severe cardiopulmonary disease, severe bradycardia, severe autonomic dysreflexia, or chronic obstructive pulmonary disease.\n* Active untreated infection such as decubitus ulcer, urinary tract infection, pneumonia\n* Presence of other active implantable medical devices with unknown or untested interaction with the NNP implant\n* Active implantable medical device (AIMD) such as a pacemaker or defibrillator, with the exception of the implanted stimulator-telemeter (IST) or implanted receiver stimulator (IRS) systems developed by the Cleveland Functional Electrical Stimulation Center\n* Unhealed fractures that prevent functional use of arm or trunk\n* Less than six months post-injury (neuroprosthesis implantation delayed until criteria met)\n* Extensive upper extremity denervation (fewer than two stimulatable hand muscles and two stimulatable trunk muscles)\n* Involvement in other ongoing clinical studies that exclude concurrent until criteria met)\n* Disorder or condition that require MRI monitoring\n* Mechanical ventilator dependency\n* Progressive SCI In subjects who are undergoing bilateral implantation, subjects should not have a history of autonomic dysreflexia, hypertension, diabetes or any condition which requires frequent blood pressure monitoring or frequent venipuncture.\n* Adverse interaction between system components and typical electromagnetic (EM) sources in subject's home and work environments, including wheelchair or other active implantable devices.","ALL","17 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is to evaluate the use of a fully implanted device for providing hand function, reach, and trunk function to individuals with cervical spinal cord injury.\n\nFunding Sources:\n\nFDA OOPD NIH NINDS",[26,27,28,29,30],"Spinal Cord Injuries","Spinal Cord Injury at C5-C7 Level","Spinal Cord Injury Cervical","Spinal Cord Injury at C5-C7 Level With Complete Lesion","Spinal Cord Injury at C5-C7 Level With Incomplete Lesion",[32,33,34,35,36,37,38,39,40,41,42,43,44],"Neuroprosthesis","Functional Electrical Stimulation","Grasp","Posture","Standing","Function","Recovery","Device","Stimulation","Implant","Reach","Independence","Activities of Daily Living","RECRUITING","2025-12-17",{"date":48,"type":49},"2025-12-19","ACTUAL",{"date":51,"type":49},"2014-12-01",{"date":53,"type":20},"2031-12-31",{"name":55,"class":56},"Anne Bryden","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":5},"100424863","phase-1-safety-and-exploratory-efficacy-of-transplantation-therapy-using-psa-ncam-npc-in-ais-a-level-of-sub-acute-sci-100424863","NCT04812431","Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI","A Single Center, Open Label, Single Group, Phase 1\u002F2a Clinical Study to Evaluate the Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC Derived From hESC Line in AIS-A Level of Sub-acute SCI(From 7 to 60 Days)","SB-SCI-001","Inclusion Criteria:\n\n1. Upon written consent of the patient or the legally acceptable representative of the patient\n2. Male and female patients 18 to 65 years of age\n3. Female patients who showed negative results on the pregnancy test, use an acceptable contraceptive or have no possibility of pregnancy (at least 2 years have elapsed after menopause or have undergone hysterectomy, ovariectomy, or sterilization operation), or male patients who have received vasectomy or are willing to use contraceptives for up to 90 days after administration of the investigational product using a dual contraceptive method\\*\n\n   \\*Dual contraceptive method: Method of using multiple contraceptives, such as using a cervical cap or contraceptive diaphragm in addition to a condom for males\n4. Patients who are capable of being administered with the investigational product on Day 7 to 60 after spinal cord injury\n5. Patients who have been confirmed to have spinal cord injury classified as AIS-A on ISNCSCI, SCIM and\u002For MRI by the investigator, physiatrist, or other spinal cord injury specialist\n6. Patients whose ASIA Impairment Scale (AIS) satisfies AIS-A criteria (spinal segment within C4-C7, complete injury)\n\nExclusion Criteria:\n\n1. Patients with spinal cord injury caused by penetrating trauma such as gunshot or stab wounds\n2. Patients with complete transection on the spinal cord\n3. Patients with spinal cord injury that require more than the mono-segment treatment\n4. Patients with other complications, including neurological defects related to peripheral nerve injury (neuromuscular injury or central spinal cord syndrome), or etiological causes of paraplegia or sensorimotor defects related to an additional underlying condition\n5. Patients with multiple lesions or lesions longer than 2 cm in length found on MRI examination\n6. Patients administered with cells excluding blood transfusion before participating in the clinical study\n7. Patients with the following intercurrent diseases or conditions:\n\n   1. Coagulopathy with INR\\> 1.4 at the time of administration of the investigational product (Day 0)\n   2. Active infection\n   3. Active hypotension requiring vasoconstrictor treatment (less than 60 mmHg of diastolic blood pressure)\n   4. Rupture of the skin on the area of surgery\n   5. Medical history of malignant tumor\n   6. Primary or secondary immunodeficiency\n   7. Clinically significant abnormal values discovered as a result of laboratory tests\n\n      * Creatinine \\> 1.5 mg\u002FdL\n      * When the level found in the liver-function examination is more than twice the upper limit of the normal level\n      * Hematocrit\u002Fhemoglobin \\\u003C30%\u002F10 g\u002FdL\n      * Total WBC \\\u003C 1000\u002FμL\n      * Uncontrolled hypertension (systole\\> 180 mmHg or diastole\\> 100 mmHg)\n      * Uncontrolled diabetes (HbA1c\\> 8%)\n      * Evidence of GI bleeding on the stool guaiac test\n      * Positive on tuberculosis test (However, a chest X-ray may be performed if found positive on the TB test, and the patient may be enrolled upon no findings that suggest active tuberculosis on the chest X-ray.)\n      * Hepatitis B or C\n      * Human Immunodeficiency Virus (HIV)\n   8. Substance abuse or alcoholism\n   9. Unstable or untreated psychiatric disorder\n8. Patients with known hypersensitivity to basiliximab, tacrolimus, mycophenolate mofetil, methylprednisolone, or prednisone\n9. Patients incapable of receiving physical therapy or combination therapy\n10. Patients incapable of going under general anesthesia due to other reasons\n11. Patients judged unsuitable for participation in this clinical study by the investigator","18 Years","65 Years",{"count":69,"type":20},5,[71,72],"PHASE1","PHASE2","This study intends to evaluate the safety and exploratory efficacy of transplantation therapy using neural precursor cells (PSA-NCAM(+) NPC) derived from the human embryonic stem cell line for the treatment of paralysis and other related symptoms from sub-acute spinal cord injury.",[75,76,29],"Spinal Cord Injury, Acute","Spinal Cord Injury at C4 Level With Complete Lesion",[78,79],"Spinal cord injury","AIS-A","2025-05-14",{"date":82,"type":49},"2025-05-18",{"date":84,"type":49},"2021-09-23",{"date":86,"type":20},"2030-09",{"name":88,"class":89},"S.Biomedics Co., Ltd.","INDUSTRY"]