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

ConditionsTraumatic 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

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age6-75

SponsorHealing Hope International

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Ecologic or community

Time perspective

Prospective

Treatments tested in this trial

MUSE Stem Cell Therapy
Biological/Vaccine
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.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: MUSE Therapy Recipients With Chronic TBI1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

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

The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a patient-reported outcome measure used to assess the severity of common post-concussive symptoms. The RPQ includes 16 items, each scored from 0 to 4, producing a total score range of 0-64, with higher scores indicating greater symptom severity. This study will evaluate the change in RPQ total score from baseline to each follow-up time point. Assessments will be conducted remotely using standardized RPQ administration procedures.

Time frame

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

Change in cognitive function (Montreal Cognitive Assessment)

The Montreal Cognitive Assessment (MoCA) is a 30-point screening instrument used to evaluate global cognitive function across multiple domains, including attention, memory, executive functioning, language, and visuospatial abilities. Higher scores indicate better cognitive performance. This study will assess change in total MoCA score from baseline to 6- and 12-month follow-up visits. Assessments will be conducted using standardized MoCA administration procedures via in-person or telehealth formats.

Time frame

Baseline; 6 and 12 months after first MUSE cell treatment

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

Health related quality of life will be assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L). The EQ-5D-5L measures health status across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted into a single summary health utility index score using country-specific value sets. Scale range: Typically less than 0 (health states worse than death) to 1.0 (perfect health) Interpretation: Higher EQ-5D-5L index scores indicate better overall health-related quality of life Changes in EQ-5D-5L index scores will be evaluated from baseline to follow-up assessments.

Time frame

Baseline; 6 and 12 months after first MUSE cell treatment

Change in functional independence (Functional Independence Measure)

Functional independence will be assessed using the Functional Independence Measure (FIM), an 18-item scale with total scores ranging from 18 to 126, higher scores indicating greater independence in activities of daily living. The outcome will be change in FIM total score from baseline to 6 and 12 months.

Time frame

Baseline; 6 and 12 months after first MUSE cell treatment

Other outcomes

Change in health care utilization related to traumatic brain injury

Health care utilization related to traumatic brain injury-including emergency department visits, unplanned hospitalizations, and outpatient neurology or rehabilitation visits-will be abstracted from participant reports and available medical records. This outcome will assess differences in the number of TBI-related visits or hospitalizations per participant-year when comparing the 12 months prior to the participant's first independently obtained MUSE cell therapy session with the 12 months following that session. All data reflect routine medical care and are not influenced or directed by the study.

Time frame

12 months before and 12 months after first MUSE cell treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Healing Hope International

Lead sponsor

Source ClinicalTrials.gov

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