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

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.

NCT Number	NCT07326059
Lead Sponsor	Healing Hope International
Conditions	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
Enrollment	10 participants
Start Date	2028-01
Primary Completion	2034-12 (estimated)
Study Completion	2036-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-10