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

NCT07326059 | Not Yet Recruiting

• 1 other identifier: HHI-TBI-MUSE-001
• Study Type: observational
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief 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.

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

Keywords

MUSE Cells; Stem Cell Therapy; Regenerative Medicine; Traumatic Brain Injury; Chronic Brain Injury; Acquired Brain Injury; Cell-Based Therapy; Neuroregeneration; Adult Neurorehabilitation; Medical Tourism; Observational Study; Real-World Evidence; Healing Hope International; Functional Recovery; Compassionate Use Registry

Outcome Measures

Primary Outcomes (1)

• Change in global functional outcome (Glasgow Outcome Scale-Extended)

  The Glasgow Outcome Scale-Extended (GOSE) is an 8-point ordinal scale (1 = Death, 8 = Upper Good Recovery) used to evaluate global functional status following traumatic brain injury. Higher scores reflect better functional outcome. This observational study will measure the change in GOSE score from baseline to 12 months after the participant's first independently obtained MUSE cell therapy session. Assessments will be conducted through structured interviews via in-person visits or telehealth, following standardized GOSE scoring procedures.

  Baseline (pre-MUSE cell treatment) and 12 months after first MUSE cell treatment

Secondary Outcomes (10)

• Change in post-concussive symptoms (Rivermead Post-Concussion Symptoms Questionnaire)

  Baseline; 3, 6, and 12 months after first MUSE cell treatment

• Change in cognitive function (Montreal Cognitive Assessment)

  Baseline; 6 and 12 months after first MUSE cell treatment

• Change in Health-Related Quality of Life Measured by EQ-5D-5L Index Score

  Baseline; 6 and 12 months after first MUSE cell treatment

• Change in functional independence (Functional Independence Measure)

  Baseline; 6 and 12 months after first MUSE cell treatment

• Change in mood and anxiety symptoms (HADS)

  Baseline; 6 and 12 months after first MUSE cell treatment

Other Outcomes (1)

• Change in health care utilization related to traumatic brain injury

  12 months before and 12 months after first MUSE cell treatment

Study Arms (1)

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.

Biological: MUSE Stem Cell Therapy

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.

MUSE Therapy Recipients With Chronic TBI

Eligibility Criteria

• Age: 6 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study population consists of individuals aged 6 to 75 with chronic traumatic brain injury who independently choose to receive MUSE stem cell therapy at licensed medical facilities outside the United States. Participants represent a real-world cohort seeking regenerative treatment as part of their personal medical care. The study does not administer therapy but follows these individuals longitudinally to document safety signals, functional outcomes, quality-of-life measures, and health care utilization over a 12-month period. Data are collected through remote assessments, participant-provided medical documentation, and available clinical records.

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.

Sponsors & Collaborators

• Healing Hope International: lead

Study Sites (2)

Healing Hope International

Houston, Texas, 77386, United States

Location

Stem Solutions

Monterrey, Nuevo León, 66278, Mexico

Location

Related Publications (3)

• Uchida H, Niizuma K, Kushida Y, Wakao S, Tominaga T, Borlongan CV, Dezawa M. Human Muse Cells Reconstruct Neuronal Circuitry in Subacute Lacunar Stroke Model. Stroke. 2017 Feb;48(2):428-435. doi: 10.1161/STROKEAHA.116.014950. Epub 2016 Dec 20.

  PMID: 27999136 BACKGROUND

• Abe T, Aburakawa D, Niizuma K, Iwabuchi N, Kajitani T, Wakao S, Kushida Y, Dezawa M, Borlongan CV, Tominaga T. Intravenously Transplanted Human Multilineage-Differentiating Stress-Enduring Cells Afford Brain Repair in a Mouse Lacunar Stroke Model. Stroke. 2020 Feb;51(2):601-611. doi: 10.1161/STROKEAHA.119.026589. Epub 2019 Dec 12.

  PMID: 31826733 BACKGROUND

• Yamauchi T, Kuroda Y, Morita T, Shichinohe H, Houkin K, Dezawa M, Kuroda S. Therapeutic effects of human multilineage-differentiating stress enduring (MUSE) cell transplantation into infarct brain of mice. PLoS One. 2015 Mar 6;10(3):e0116009. doi: 10.1371/journal.pone.0116009. eCollection 2015.

  PMID: 25747577 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Brain Injury, Chronic; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Lambert Abeyatunge, MD: Regenerative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamara C Director of Clinical Research, MS. Biopharmaceutical RA

CONTACT

18633545131; tamara.c.tamas@gmail.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 8, 2026
• Study Start (Estimated): January 1, 2028
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): June 30, 2036
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

ME (1); US (1)