Traumatic Brain InjuryMUSE-TBI-OBSNCT07326059
Safety and Outcomes of MUSE Stem Cell Therapy in Individuals With Traumatic Brain Injury
An observational study of Traumatic Brain Injury and Traumatic Brain Injury (TBI) Patients, run by Healing Hope International at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 75 years
- Conditions the study is for
- Traumatic Brain Injury, Traumatic Brain Injury (TBI) Patients, Traumatic Brain Injury (TBI); Concussion, Initial Encounter
- What is being tested?
- MUSE Stem Cell Therapy
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2028to 30 Jun 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Tamara C Director of Clinical Research, MS. Biopharmaceutical RA contact
2 sites in 2 countries
United States1 site
Healing Hope International
Houston, Texas, 77386
Tamara C Tamas, MS Regulatory Affairs, 8633545131, tamara.c.tamas@gmail.com
Mexico1 site
Stem Solutions
Monterrey, Nuevo León, 66278
Dr. Anna L Kattan, MD Regenerative Medicine, +1 956 476 4207, anna@stemsolutions.mx
About this study
Official title: An Observational Study on the Safety and Outcomes of MUSE Stem Cell Therapy in Participants With Traumatic Brain Injury Receiving International Clinical Treatment
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.
Read the detailed description
This observational study is designed to systematically evaluate the safety, tolerability, and potential neurological outcomes associated with MUSE (Multilineage-differentiating Stress-Enduring) stem cell therapy in individuals with chronic traumatic brain injury (TBI) who independently obtain treatment through international clinical programs.
MUSE cells are a distinct subpopulation of mesenchymal stem cells characterized by stress resilience, spontaneous triploblastic differentiation, and the capacity to home to sites of tissue injury. Preclinical research suggests that MUSE cells may contribute to neuroregeneration through differentiation into neural and glial lineages, modulation of inflammatory pathways, and repair of damaged central nervous system structures. While early findings are promising, clinical evidence remains limited, highlighting the need for structured real-world data.
This study does not randomize participants or administer any treatment. Instead, it functions as a registry-style, real-world evidence platform following individuals who have elected to receive MUSE cell therapy at licensed facilities outside the United States. Collected data will include baseline demographics, TBI history, details of the stem cell procedure (such as cell source, administered dose, and route of delivery), and longitudinal follow-up over 12 months.
Primary domains of interest include:
Neurological function, assessed with validated clinical instruments (e.g., Glasgow Outcome Scale-Extended).
Quality of life, measured using standardized patient-reported outcome tools (e.g., PROMIS-29, EQ-5D).
Functional abilities and activities of daily living, to assess practical day-to-day impact.
Safety and tolerability, including documentation of adverse events, patient-reported symptoms, and any medical complications.
Data will be obtained through remote telemedicine visits, structured digital surveys, and review of available medical records. This study does not collect biospecimens and does not involve the administration of any investigational product.
The overarching objective is to generate high-quality real-world evidence regarding the use of MUSE stem cells in chronic TBI, supporting the scientific foundation needed for future controlled clinical trials and potential compassionate use pathways. The study is conducted by Healing Hope International, a nonprofit organization dedicated to advancing ethical access and research in regenerative medicine.
- 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
- Being tested
- MUSE Stem Cell Therapy
- 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
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Brain Injury, Chronic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUSE Stem Cell TherapyBiological
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: MUSE Stem Cell Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; 6 and 12 months after first MUSE cell treatment
Change in mood and anxiety symptoms (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire with two subscales-HADS-Anxiety and HADS-Depression-each scored from 0 to 21, with higher scores indicating more severe symptoms. This study will evaluate changes in HADS-Anxiety and HADS-Depression subscale scores from baseline to 6- and 12-month follow-up assessments. The HADS will be administered using standardized procedures through remote or in-person data collection.
Measured: Baseline; 6 and 12 months after first MUSE cell treatment
Change in Interleukin-6 (IL-6) Serum Concentration
Serum concentrations of Interleukin-6 (IL-6), a pro-inflammatory cytokine associated with chronic traumatic brain injury, will be obtained when available from participants' independently ordered clinical laboratory tests. IL-6 values will be abstracted from medical records or participant-provided laboratory reports. The study team does not order laboratory testing, collect biospecimens, or perform assays.
Unit of measure: picograms per milliliter (pg/mL)
Interpretation: Higher IL-6 concentrations indicate greater systemic inflammation
Changes in IL-6 concentrations will be evaluated between baseline and follow-up time points.
Measured: Baseline; 3 and 6 months after first MUSE cell treatment
Incidence of treatment-emergent serious adverse events
Serious adverse events (SAEs) will be documented using participant reports and available medical records. SAEs will be classified according to ICH and FDA definitions, including events resulting in death, life-threatening conditions, hospitalization or its prolongation, persistent or significant disability/incapacity, or other medically significant events. This study will record the number and proportion of participants experiencing at least one SAE, as well as the total number of SAEs reported during the observation period.
Measured: From first MUSE cell treatment through 12 months of follow-up
Change in Self-Rated Health Measured by Visual Analogue Scale (EQ-VAS)
Self-perceived overall health status will be assessed using the EuroQol Visual Analogue Scale (EQ-VAS). The EQ-VAS is a validated vertical visual analogue scale on which participants rate their current health status. Scale range: 0 to 100
0 = Worst imaginable health state
100 = Best imaginable health state
Interpretation: Higher EQ-VAS scores indicate better self-rated health
Changes in EQ-VAS scores will be evaluated from baseline to follow-up assessments.
Proxy-reported responses will be permitted when participants are unable to self-report due to neurological impairment.
Measured: Baseline, 6 months, and 12 months after first MUSE cell treatment
Change in Tumor Necrosis Factor Alpha (TNF-α) Serum Concentration
Serum concentrations of Tumor Necrosis Factor Alpha (TNF-α), a pro-inflammatory cytokine implicated in neuroinflammation and secondary injury following traumatic brain injury, will be obtained when available from participants' independently ordered clinical laboratory tests. TNF-α values will be abstracted from medical records or participant-provided laboratory reports. No laboratory testing or biospecimen collection is performed by the study team.
Unit of measure: picograms per milliliter (pg/mL)
Interpretation: Higher TNF-α concentrations indicate greater inflammatory activity
Changes in TNF-α concentrations will be evaluated between baseline and follow-up time points.
Measured: Baseline, 3 months, and 6 months after first MUSE cell treatment
Change in C-Reactive Protein (CRP) Serum Concentration
Serum concentrations of C-Reactive Protein (CRP), a systemic inflammatory biomarker commonly associated with chronic inflammation and injury response, will be obtained when available from participants' independently ordered clinical laboratory tests. CRP values will be abstracted from medical records or participant-provided laboratory reports. The study does not order laboratory testing or collect biospecimens.
Unit of measure: milligrams per liter (mg/L)
Interpretation: Higher CRP concentrations indicate greater systemic inflammation
Changes in CRP concentrations will be evaluated between baseline and follow-up time points.
Measured: Time Frame: Baseline, 3 months, and 6 months after first MUSE cell treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study startJan 2028 (estimated)
- Primary completionDec 2034 (estimated)
- Study completion30 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healing Hope International
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Lambert Abeyatunge, MD: Regenerative Medicine, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326059
- Sponsor's protocol ID
- HHI-TBI-MUSE-001
- Acronym
- MUSE-TBI-OBS
- Status last verified
- Mar 2026
- First submitted
- 8 Dec 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27999136Abe 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.
PubMed 31826733Yamauchi 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.
PubMed 25747577
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Safety and Outcomes of MUSE Stem Cell Therapy in Participants With Traumatic Brain Injury Receiving International Clinical Treatment
- ClinicalTrials.gov ID
- NCT07326059
- Acronym / sponsor ID
- MUSE-TBI-OBS / HHI-TBI-MUSE-001
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Healing Hope InternationalUniversity, hospital or other
- Study start
- Jan 2028 (estimated)
- Primary completion
- Dec 2034 (estimated)
- Study completion
- 30 Jun 2036 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This observational study is designed to systematically evaluate the safety, tolerability, and potential neurological outcomes associated with MUSE (Multilineage-differentiating Stress-Enduring) stem cell therapy in individuals with chronic traumatic brain injury (TBI) who independently obtain treatment through international clinical programs.
MUSE cells are a distinct subpopulation of mesenchymal stem cells characterized by stress resilience, spontaneous triploblastic differentiation, and the capacity to home to sites of tissue injury. Preclinical research suggests that MUSE cells may contribute to neuroregeneration through differentiation into neural and glial lineages, modulation of inflammatory pathways, and repair of damaged central nervous system structures. While early findings are promising, clinical evidence remains limited, highlighting the need for structured real-world data.
This study does not randomize participants or administer any treatment. Instead, it functions as a registry-style, real-world evidence platform following individuals who have elected to receive MUSE cell therapy at licensed facilities outside the United States. Collected data will include baseline demographics, TBI history, details of the stem cell procedure (such as cell source, administered dose, and route of delivery), and longitudinal follow-up over 12 months.
Primary domains of interest include:
Neurological function, assessed with validated clinical instruments (e.g., Glasgow Outcome Scale-Extended).
Quality of life, measured using standardized patient-reported outcome tools (e.g., PROMIS-29, EQ-5D).
Functional abilities and activities of daily living, to assess practical day-to-day impact.
Safety and tolerability, including documentation of adverse events, patient-reported symptoms, and any medical complications.
Data will be obtained through remote telemedicine visits, structured digital surveys, and review of available medical records. This study does not collect biospecimens and does not involve the administration of any investigational product.
The overarching objective is to generate high-quality real-world evidence regarding the use of MUSE stem cells in chronic TBI, supporting the scientific foundation needed for future controlled clinical trials and potential compassionate use pathways. The study is conducted by Healing Hope International, a nonprofit organization dedicated to advancing ethical access and research in regenerative medicine.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MUSE Therapy Recipients With Chronic TBI | – | Biological: MUSE Stem Cell TherapyThis 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. |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MUSE Stem Cell TherapyMUSE (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. | Biological | MUSE Therapy Recipients With Chronic TBI |
Primary outcome
Change in global functional outcome (Glasgow Outcome Scale-Extended)
Time frame: Baseline (pre-MUSE cell treatment) and 12 months after first MUSE cell treatment
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.
10 secondary outcomes
Change in post-concussive symptoms (Rivermead Post-Concussion Symptoms Questionnaire)
Time frame: Baseline; 3, 6, and 12 months after first MUSE cell treatment
Change in cognitive function (Montreal Cognitive Assessment)
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
Time frame: Baseline; 6 and 12 months after first MUSE cell treatment
Change in functional independence (Functional Independence Measure)
Time frame: Baseline; 6 and 12 months after first MUSE cell treatment
Change in mood and anxiety symptoms (HADS)
Time frame: Baseline; 6 and 12 months after first MUSE cell treatment
Change in Interleukin-6 (IL-6) Serum Concentration
Time frame: Baseline; 3 and 6 months after first MUSE cell treatment
Incidence of treatment-emergent serious adverse events
Time frame: From first MUSE cell treatment through 12 months of follow-up
Change in Self-Rated Health Measured by Visual Analogue Scale (EQ-VAS)
Time frame: Baseline, 6 months, and 12 months after first MUSE cell treatment
Change in Tumor Necrosis Factor Alpha (TNF-α) Serum Concentration
Time frame: Baseline, 3 months, and 6 months after first MUSE cell treatment
Change in C-Reactive Protein (CRP) Serum Concentration
Time frame: Time Frame: Baseline, 3 months, and 6 months after first MUSE cell treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 27999136Uchida 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.
- Background: PubMed 31826733Abe 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.
- Background: PubMed 25747577Yamauchi 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.
- Individual participant dataSharing planned: Undecided
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tamara C Director of Clinical Research, MS. Biopharmaceutical RA contact
Dr. Lambert Abeyatunge, MD: Regenerative Medicine principal investigator
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Traumatic Brain Injury (TBI) Patients, run by Healing Hope International at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tamara C Director of Clinical Research, MS. Biopharmaceutical RA (18633545131, tamara.c.tamas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07326059, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.