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

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

Eligibility Criteria

Sex

ALL

Age

6 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• MUSE Stem Cell Therapy — BIOLOGICAL
  MUSE (Multilineage-differentiating Stress-Enduring) stem cell therapy refers to the use of a naturally occurring subpopulation of mesenchymal lineage cells characterized by stress tolerance, expression of SSEA-3, and the capacity to differentiate into multiple cell types. Preclinical studies have shown that MUSE cells can migrate to sites of tissue injury, including the central nervous system, and may contribute to tissue repair through paracrine and regenerative mechanisms. In this observational study, participants independently obtain MUSE stem cell therapy at licensed treatment facilities outside the United States as part of their personal medical care. The study team does not provide, administer, manufacture, or direct the therapy.

Study Details

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 Dates

Start date

Jan 31, 2028

Status verified

Mar 2026

Primary completion

Dec 31, 2034

Completion

Jun 30, 2036

Study Design

Enrollment

10 participants (estimated)

Arms

• Arm: MUSE Therapy Recipients With Chronic TBI
  This cohort includes individuals aged 6 to 75 with chronic traumatic brain injury (TBI) who independently elect to receive MUSE (Multilineage-differentiating Stress-Enduring) stem cell therapy at licensed international treatment centers outside the United States. The study does not provide or administer the therapy; instead, it observes and documents real-world outcomes following treatment. Participants may receive MUSE cell infusions using varying doses, cell sources, and routes of administration, depending on the clinical site they choose. The study will collect longitudinal data on neurological function, quality of life, functional independence, and any adverse events over a 12-month follow-up period.

Primary Outcome Measure

Change in global functional outcome (Glasgow Outcome Scale-Extended) [ Time Frame: Baseline (pre-MUSE cell treatment) and 12 months after first MUSE cell treatment ]

Central Contacts

• Tamara C Director of Clinical Research, MS. Biopharmaceutical RA
  18633545131
  [email protected]

Locations (1)

Find similar trials in Houston, TX

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