Safety and Outcomes of MUSE Stem Cell Therapy in Individuals With Traumatic Brain Injury (NCT07326059) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Outcomes of MUSE Stem Cell Therapy in Individuals With Traumatic Brain Injury
United States, Mexico10 participantsStarted 2028-01
Plain-language summary
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.
The 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.
This 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.
Who can participate
Age range
6 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in global functional outcome (Glasgow Outcome Scale-Extended)
Timeframe: Baseline (pre-MUSE cell treatment) and 12 months after first MUSE cell treatment
Trial details
NCT IDNCT07326059
SponsorHealing Hope International
Sponsor typeOTHER
Study typeOBSERVATIONAL
Primary completion2034-12
Contact for this trial
Tamara C Director of Clinical Research, MS. Biopharmaceutical RA