[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"traumatic-brain-injury-tbi-concussion-subsequent-encounter\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:traumatic-brain-injury-tbi-concussion-subsequent-encounter":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":58},"100618010","safety-and-outcomes-of-muse-stem-cell-therapy-in-individuals-with-traumatic-brain-injury-100618010",false,"NCT07326059","Safety and Outcomes of MUSE Stem Cell Therapy in Individuals With Traumatic Brain Injury","An Observational Study on the Safety and Outcomes of MUSE Stem Cell Therapy in Participants With Traumatic Brain Injury Receiving International Clinical Treatment","MUSE-TBI-OBS","Inclusion Criteria:\n\nIndividuals aged 6 to 75 years at the time of enrollment.\n\nDocumented history of traumatic brain injury (TBI) occurring at least 6 months prior to enrollment (chronic phase).\n\nParticipant has independently elected to receive MUSE (Multilineage-differentiating Stress-Enduring) stem cell therapy at a licensed treatment facility outside the United States.\n\nAbility of the participant or legally authorized representative to provide informed consent for participation in an observational study.\n\nWillingness to participate in remote or in-person follow-up assessments for up to 12 months.\n\nAbility to provide medical records, laboratory reports, or treatment documentation when available.\n\nExclusion Criteria:\n\nIndividuals who have not received, and do not plan to receive, MUSE cell therapy as part of their independent medical care.\n\nInability or unwillingness to complete study assessments (e.g., severe communication barriers not manageable through caregiver assistance or technology).\n\nAny condition that, in the opinion of the study team, would make participation in an observational registry unsafe or infeasible (e.g., inability to provide minimal required data).\n\nPlanned participation in another research study that would prevent collection of observational outcomes for this registry.\n\nIndividuals currently incarcerated or in institutional settings where research participation is restricted.\n\n\\-","ALL","6 Years","75 Years",{"count":21,"type":22},10,"ESTIMATED","OBSERVATIONAL","This prospective observational study evaluates the safety profile and patient-reported outcomes associated with MUSE (Multilineage-differentiating Stress-Enduring) stem cell therapy in individuals aged 6 to 75 with chronic traumatic brain injury (TBI). Participants independently elect to receive MUSE cell treatment through international clinical programs, and this study aims to capture real-world evidence on the potential therapeutic effects and risks of this emerging regenerative approach.\n\nThe study does not administer any intervention. Instead, it follows participants who have received, or plan to receive, MUSE cell infusions outside the United States. Over a 12-month follow-up period, data will be collected on neurological functioning, quality of life, activities of daily living, and any reported adverse events or complications. Information will be gathered through remote interviews, structured digital surveys, and review of medical documentation when available.\n\nThis research is sponsored by Healing Hope International and is intended to contribute to the ethical and responsible advancement of novel cell-based therapies by generating real-world evidence that may guide future clinical trial development and inform patient care practices.",[26,27,28,29,30,31],"Traumatic Brain Injury","Traumatic Brain Injury (TBI) Patients","Traumatic Brain Injury (TBI); Concussion, Initial Encounter","Traumatic Brain Injury (TBI); Concussion, Subsequent Encounter","Traumatic Brain Injury With Brief Loss of Consciousness","Traumatic Brain Injury With Persistent Cognitive Deficits",[33,34,35,26,36,37,38,39,40,41,42,43,44,45,46],"MUSE Cells","Stem Cell Therapy","Regenerative Medicine","Chronic Brain Injury","Acquired Brain Injury","Cell-Based Therapy","Neuroregeneration","Adult Neurorehabilitation","Medical Tourism","Observational Study","Real-World Evidence","Healing Hope International","Functional Recovery","Compassionate Use Registry","NOT_YET_RECRUITING","2026-03-08",{"date":50,"type":51},"2026-03-10","ACTUAL",{"date":53,"type":22},"2028-01",{"date":55,"type":22},"2036-06-30",{"name":44,"class":57},"OTHER",2]