Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07326059
Eligibility Criteria:
Inclusion Criteria:
Individuals aged 6 to 75 years at the time of enrollment.
Documented history of traumatic brain injury (TBI) occurring at least 6 months prior to enrollment (chronic phase).
Participant has independently elected to receive MUSE (Multilineage-differentiating Stress-Enduring) stem cell therapy at a licensed treatment facility outside the United States.
Ability of the participant or legally authorized representative to provide informed consent for participation in an observational study.
Willingness to participate in remote or in-person follow-up assessments for up to 12 months.
Ability to provide medical records, laboratory reports, or treatment documentation when available.
Exclusion Criteria:
Individuals who have not received, and do not plan to receive, MUSE cell therapy as part of their independent medical care.
Inability or unwillingness to complete study assessments (e.g., severe communication barriers not manageable through caregiver assistance or technology).
Any 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).
Planned participation in another research study that would prevent collection of observational outcomes for this registry.
Individuals currently incarcerated or in institutional settings where research participation is restricted.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
75 Years
Study:
NCT07326059
Study Brief:
Protocol Section:
NCT07326059