Safety and Outcomes of MUSE Stem Cell Therapy in Individuals With Traumatic Brain Injury

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Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT07326059

Run by

Healing Hope International

People needed

10

Starts

2028-01-01

Expected to finish

2036-06-30

Last updated by the study team

2026-03-10

Who can join

Age: 6 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Healing Hope International — Houston, Texas, United States
• Stem Solutions — Monterrey, Nuevo León, Mexico

Full record on ClinicalTrials.gov

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