[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Q Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100353852","phase-1-study-to-investigate-the-safety-of-the-transplantation-of-human-glial-restricted-progenitor-cells-into-subjects-with-transverse-myelitis-100353852",false,"NCT03887273","Study to Investigate the Safety of the Transplantation of Human Glial Restricted Progenitor Cells Into Subjects With Transverse Myelitis","A Phase 1\u002F2a Open-Label Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Transverse Myelitis (TM)","Inclusion Criteria:\n\n1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to collect and use protected health information (PHI) in accordance with national and local subject privacy regulations.\n2. Live within reasonable travel distance to center or have reliable mechanism to travel to the center.\n3. Have a caregiver willing\u002Fable to assist in the transportation and care required by study participation.\n4. Subject is 18 - 70 years of age (inclusive) on day of Screening Visit.\n5. Subject is diagnosed with idiopathic TM within the past 120 months in accord with the Transverse Myelitis Consortium Working Group (2002).\n6. Subject has an MRI with a single focus of T2 hyperintensity with its most rostral extent at or below C8 myotome\u002Fdermatome level.\n7. Subject has negative NMO IgG (anti-AQP4) test at two separate time points, separated by at least 6 months.\n8. Subject has brain MRI not consistent with multiple sclerosis or other autoimmune or demyelinating disease.\n9. Subject is more than 12 months from TM onset.\n10. Subject has ASIA A, B or C categorization, and is unable to ambulate (Cohort A) or unable to ambulate 100 feet without significant bilateral support. (Cohort B).\n11. Subject's neurological deficits related to TM have been stable for at least 3 months.\n12. Subject is medically able to undergo the study procedures and physically able to adhere to the visit schedule at the time of study entry.\n13. For women of child bearing capacity, negative pregnancy test during the Screening Period and at the Pre-Operative Visit.\n14. Males and females will agree to practice effective birth control during study participation and up to one year after.\n15. Current, up to date, COVID vaccination.\n16. Current, up to date, varicella zoster vaccination.\n17. Current, seasonally up to date, influenza vaccination.\n\nExclusion Criteria:\n\n1. Subject with causes of weakness, sensory loss and\u002For autonomic dysfunction other than TM have not been practically excluded.\n2. Subject with significant cognitive impairment, clinical dementia, or major psychiatric illness including psychosis, bipolar disease, major depression, as determined by the DSM-V that will interfere with participation in the trial.\n3. Subject with a diagnosis of a neurodegenerative disease (e.g., ALS, Parkinson's disease, Alzheimer's disease).\n4. Subject suffering with medical conditions that impair nerve or muscle function (e.g., notable peripheral neuropathy, metabolic muscle disease) or any disease or condition that would impair the subject's neuromuscular function or impair the adequate assessment of the subject's function (e.g., severe osteoarthritis).\n5. Subject with a clinically significant history of unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active malignancy or infectious disease or other medically significant illness that may render them at an unacceptable risk for surgery or that may cause them to be unable to complete the scheduled duration of the trial.\n6. History of spine surgery or anatomic variation incompatible with route of administration (as determined by neurosurgeon).\n7. Severe spinal stenosis or cord compression causing myelopathy.\n8. Abnormal flow voids on the surface of the spinal cord suggestive of arteriovenous malformation (AVM) or evidence of a vascular cause of a myelopathy (e.g., infarct of spinal artery).\n9. Any evidence of CNS malignancy or clinically significant CNS lesions as defined by imaging studies of the CNS (MRI of brain and spinal cord).\n10. Uncontrolled hypertension (Systolic BP\\>180mmHg and\u002For Diastolic BP \\>110mmHg).\n11. Any poorly controlled medical conditions that, in the opinion of the site investigator and\u002For surgeon, increase risk of surgery to a medically unacceptable degree.\n12. Subjects who cannot undergo MRI examination because of any contraindication to the procedure, including the presence of a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic devices, or who have been or might have been exposed to metal fragments, or any reason the subject cannot undergo an MRI routinely for the duration of the trial.\n13. Subject with clinically significant abnormal clinical laboratory values, as determined by the Investigator at the screening visit (Visit 1).\n14. Subject who is immune compromised (by therapeutic agent or disease) or who has a condition contraindicated to treatment with immunosuppression agents (e.g., tuberculosis, latent infection) as determined by history or testing. Any subject with an ongoing infection until it has been adequately treated and it is deemed to be resolved.\n15. Subject with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value \\>3.0 times the upper limit of normal at the screening visit (Visit 1).\n16. Subject with diabetes or HgbA1c \\> 6.5.\n17. Subject with a history of alcohol or drug abuse or dependence within 1 year of screening visit (Visit 1), per DSM-V criteria.\n18. Subject unlikely to comply with study requirements, as determined by Investigator.\n19. Subject who has been exposed to any other experimental agent (off-label use or investigational) within 60 days of screening visit (Visit 1). Biologic agents may need additional time for washout and will be evaluated by the Sponsor on a case-by-case basis.\n20. Subject with pre-existing severe or high titer anti-human leukocyte antigen (HLA) class I or class II antibodies directed against the Q-Cells®, as determined by panel reactive antibody (PRA) assay.\n21. Allergy to study treatment (Q-Cells®) or any of its constituents (e.g., chicken eggs), or allergy to any of the co-administered immunosuppressants or any of their excipients.\n22. Subject with any medical condition or using concomitant medication that would contraindicate the use of tacrolimus, mycophenolate mofetil, or prednisone as determined by Investigator.\n23. Subject has undergone stem cell transplantation (including T-cell or bone marrow transplants) at any time prior to study (within or outside the US).\n24. Subject with prior embolus or evidence of deep vein thrombosis (DVT) by venous ultrasound without adequate treatment.\n25. Subject has recent (1 year) or recurrent history of gastrointestinal bleeding or peptic ulcer disease or is under active treatment to prevent recurrence.\n26. Subject with estimated glomerular filtration rate at screening of less than 60 mL\u002Fmin\u002F1.73m2.\n27. Subjects with hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.\n28. Vaccination with live virus within 6 weeks of screening.\n29. History or evidence of optic neuritis.\n30. Any reason, in the judgment of the investigator, which would make the subject inappropriate for entry into this trial.","ALL","18 Years","70 Years",{"count":20,"type":21},9,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is a non-randomized, open-label, partially blinded, sequential cohort, dose-escalation study designed to obtain preliminary data on the safety, tolerability, and early activity of Q-Cells® transplantation in subjects with Transverse Myelitis. For each of the dose levels, transplantation of Q-Cells® unilaterally into spinal cord demyelinated lesions will be evaluated. Subjects will be blinded to side of treatment.",[28],"Transverse Myelitis",[30],"TM","RECRUITING","2026-07-20",{"date":34,"type":35},"2026-07-21","ACTUAL",{"date":37,"type":35},"2022-09-20",{"date":39,"type":21},"2028-12",{"name":41,"class":42},"Q Therapeutics, Inc.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100245822","phase-1-study-to-investigate-the-safety-of-the-transplantation-by-injection-of-human-glial-restricted-progenitor-cells-hgrps-q-cells-into-subjects-with-amyotrophic-lateral-sclerosis-als-100245822","NCT02478450","Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Amyotrophic Lateral Sclerosis (ALS)","A Phase 1\u002F2a Open-Label Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Amyotrophic Lateral Sclerosis (ALS): Assessment of Localized Therapeutic Activity by Blinded Observation and Lateral Transplantation (ALTA-BOLT)","Inclusion Criteria:\n\n1. Subject has the ability to understand the purpose and risks of the study and provide a signed and dated informed consent and authorization to collect and use protected health information (PHI) in accordance with national and local subject privacy regulations.\n2. Subject lives within reasonable driving distance of study center (approximately 3 hours).\n3. Subject has a caregiver willing\u002Fable to assist in the transportation and care required by study participation.\n4. Subject is 18 - 80 years of age (inclusive) on the first day of the Screening Period.\n5. Subject is diagnosed with sporadic or familial ALS within the past 48 months.\n6. Subject meets the laboratory-supported probable, clinically probable, or definite criteria for diagnosing ALS according to the World Federation of Neurology El Escorial criteria.\n7. Subject has an upright FVC ≥65% of predicted value for age, height, and gender at Screening.\n8. Subject has not taken riluzole for at least 30 days prior to the first day of the Screening Period, or has been on a stable dose of riluzole for at least 30 days prior to the first day of the Screening Period (Riluzole-naïve subjects are permitted in the study).\n9. Subject is medically able to undergo the study procedures and physically able to adhere to the visit schedule at the time of study entry.\n10. Women of childbearing capacity must have a negative pregnancy test during the Screening Period and at the Pre-Operative Visit.\n11. Subject must agree to practice effective birth control during study participation.\n\nExclusion Criteria:\n\n1. Subject in whom causes of neuromuscular weakness other than ALS have not been practically excluded.\n2. Subject with a diagnosis of significant cognitive impairment, clinical dementia, or major psychiatric illness including psychosis, bipolar disease, major depression, as determined by the DSM-V.\n3. Subject with a diagnosis of other neurodegenerative disease (e.g., Parkinson's disease, Alzheimer's disease).\n4. Subject with a diagnosis of any medical condition that impairs nerve or muscle function (e.g., notable peripheral neuropathy, metabolic muscle disease).\n5. Subject with a clinically significant history of unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active malignancy or infectious disease or other medically significant illness, which, in the opinion of the Investigator, would preclude study participation.\n6. Subject with a history of spine surgery or anatomic variation incompatible with route of administration (as determined by neurosurgeon).\n7. Subject with severe cervical or lumbar stenosis, cord compression, or cervical or lumbar myelopathy.\n8. Subject with abnormal flow voids on the surface of the spinal cord suggestive of arteriovenous malformation (AVM).\n9. Subject demonstrating any evidence of CNS malignancy or CNS lesions as defined by imaging studies of the CNS (MRI of brain and spinal cord).\n10. Subject having uncontrolled hypertension (Systolic BP\\>180mmHg and\u002For Diastolic BP \\>110mmHg) or having a history of thrombotic events or poorly controlled medical conditions that, in the opinion of the Investigator and\u002For surgeon, increase risk of surgery.\n11. Subject who cannot undergo MRI examination because of the presence of a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic devices, or who have been or might have been exposed to metal fragments, or any reason the subject cannot undergo an MRI routinely for the duration of the trial.\n12. Subject with clinically significant abnormal clinical laboratory values, as determined by the Investigator during the Screening Period.\n13. Subject who is immune compromised or who has a condition contraindicated to treatment with immunosuppression agents (e.g., tuberculosis, latent infection).\n14. Subject with an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value \\>3.0 times the upper limit of normal or creatinine \\>1.5 times the upper limit of normal and\u002For eGFR \\\u003C50cc\u002Fmin during the Screening Period.\n15. Subject with a history of alcohol or drug abuse or dependence within 1 year of the first day of the Screening Period, per DSM-V criteria.\n16. Subject unlikely to comply with study requirements, as determined by Investigator.\n17. Subject who has been exposed to any other experimental agent (off-label use or investigational) within 30 days of the first day of the Screening Period. Biologic agents may need additional time for washout and will be evaluated by the Sponsor on a case-by-case basis.\n18. Subject who has previously been administered stem cells.\n19. Subject with pre-existing anti-human leukocyte antigen (HLA) class I or class II antibodies directed against the Q-Cells®, as determined by panel reactive antibody (PRA) assay during the Screening Period.\n20. Subject with an allergy to Q-Cells® or any of its constituents (e.g., chicken eggs), or an allergy to any of the co-administered immunosuppressants or any of their excipients.\n21. Subject with any medical condition or using concomitant medication that would contraindicate the use of tacrolimus, mycophenolate mofetil, or prednisone as determined by Investigator.\n22. Subject with evidence of deep vein thrombosis (DVT) by venous ultrasound or any previous evidence of DVT.\n23. Subject who, in the opinion of the Investigator, has taken or is taking concomitant medications, supplements, or other agents that may interfere with the safety evaluation of Q-Cells® or may affect the course of the subject's ALS progression.",{"count":52,"type":21},30,[24,25],"This study is a non-randomized, open-label, partially blinded, sequential cohort, dose-escalation study designed to obtain preliminary data on the safety, tolerability, and early efficacy of Q-Cells® transplantation in subjects with ALS. Following an initial cohort receiving cell transplants unilaterally in the lumbar spinal cord, subsequent cohorts will receive escalating doses transplanted unilaterally in cervical spinal cord. Subjects and outcome measure assessors will be blinded to side of treatment. The study will be conducted at sites with extensive clinical experience with the care of patients with ALS.",[56],"Amyotrophic Lateral Sclerosis","NOT_YET_RECRUITING","2026-07-06",{"date":60,"type":35},"2026-07-08",{"date":62,"type":21},"2026-12",{"date":64,"type":21},"2029-12",{"name":41,"class":42},""]