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Traumatic Brain InjuryMuSE-INSIGHTNCT07521384

Real World Outcomes of Intranasal MuSE Exosomes and Stem Cells in Neurological Regenerative Therapy

An observational study of Traumatic Brain Injury and Cerebral Palsy, run by Healing Hope International at 1 site in Mexico.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This prospective observational study collects real world data on participants receiving regenerative therapies administered internationally and delivered intranasally via the Kurve Therapeutics ViaNase device. The study does not assign treatment. Read more about this study

Who is it for?
Ages 4 to 80 years
How many people
36 participants
Where
1 siteMexico
Study dates
1 Jun 2026to 30 Jan 2029
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 4 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: This study includes pediatric and adult participants with neurologic conditions receiving intranasal regenerative therapies administered outside the study protocol. Participants are enrolled into observational cohorts based on treatment type and followed prospectively to evaluate changes in inflammatory biomarkers, including TNF-α, as well as safety and clinical outcomes over time.

Who may be able to join

  • Participant has a documented diagnosis of a neurologic condition, including but not limited to: traumatic brain injury, cerebral palsy, hypoxic-ischemic encephalopathy, stroke, or other neurologic disorders
  • Participant has received or is scheduled to receive intranasal therapy using MuSE cell-derived exosomes, MuSE stem cells, or combination therapy administered via the Kurve Therapeutics ViaNase system as part of clinical care outside the study protocol
  • Baseline serum TNF-α measurement is available or can be obtained prior to treatment
  • Participant or legally authorized representative is able to provide informed consent
  • Willingness to participate in follow-up assessments, including laboratory and clinical outcome measures
  • Stable clinical status for at least 2 weeks prior to baseline assessment

Who cannot join

  • Active systemic infection at the time of enrollment
  • Use of systemic immunosuppressive or biologic anti-inflammatory therapies that may significantly alter TNF-α levels within 30 days prior to baseline measurement
  • Inability to obtain baseline or follow-up TNF-α measurements
  • Incomplete documentation of treatment type, dose, or administration method
  • Any medical condition that, in the opinion of the investigator, would interfere with interpretation of study outcomes

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mexico1 site

  • Stem Solutions

    Monterrey, Nuevo León

Other trials in Mexico

About this study

Official title: Prospective Observational Multi Cohort Study of Intranasal MuSE Cell Derived Exosomes, MuSE Stem Cells, and Combination Therapy Delivered Via the Kurve Therapeutics ViaNase Device in Patients Receiving International Regenerative Treatments

This prospective observational study collects real world data on participants receiving regenerative therapies administered internationally and delivered intranasally via the Kurve Therapeutics ViaNase device. The study does not assign treatment. Participants are enrolled after receiving, or electing to receive, therapy as part of routine clinical care outside the study.

Participants are observed in one of three cohorts based on the therapy received: MuSE cell derived exosomes, MuSE stem cells, or combination therapy. The objective is to evaluate safety, tolerability, and changes in inflammatory biomarkers and clinical outcomes over time in a real world setting. The study also evaluates changes in inflammatory biomarkers, including serum tumor necrosis factor alpha (TNF-α), to better understand the biological effects of these therapies.

Read the detailed description

This is a prospective, multi cohort observational study designed to collect real world data on participants receiving regenerative therapies administered outside the study protocol and delivered intranasally via the Kurve Therapeutics ViaNase device.

The study does not assign interventions. Participants are enrolled after treatment decisions have been made by the treating clinician and patient as part of routine clinical care in international settings. Participants are categorized into observational cohorts based on the therapy received.

The study includes the following cohorts:

Cohort 1: Participants receiving 100 billion MuSE cell-derived exosomes administered intranasally via the ViaNase device Cohort 2: Participants receiving 50 million MuSE stem cells administered intranasally via the ViaNase device Cohort 3: Participants receiving combination therapy consisting of 100 billion MuSE cell-derived exosomes and 50 million MuSE stem cells administered intranasally via the ViaNase device

Dosing and treatment regimens are determined by the treating clinician and may vary based on individual patient factors and clinical protocols.

The primary objective is to characterize safety, tolerability, and changes in inflammatory biomarkers in a real world setting. Secondary objectives include evaluating trends in clinical outcomes, functional status, neurologic symptoms, and quality of life over time.

A key objective of this study is to evaluate changes in inflammatory biomarkers, including serum tumor necrosis factor alpha (TNF-α), measured at baseline and follow-up intervals. These biomarkers are used to explore the potential biological effects of intranasally delivered MuSE-derived therapies across treatment cohorts.

Data will be collected prospectively at baseline and predefined follow-up intervals, including approximately 1 month and 3 months post-treatment, using a combination of patient-reported outcomes, caregiver assessments, laboratory measurements, and available clinical documentation. Outcomes may include changes in functional performance, symptom burden, healthcare utilization, and biomarker levels.

This observational design enables the systematic collection of real-world evidence associated with internationally delivered regenerative therapies while maintaining separation between clinical care and research data collection.

Findings from this study may inform future controlled clinical trials and support hypothesis generation for regenerative medicine approaches targeting inflammatory and neurologic conditions.

Keywords
MuSE stem cells, MuSE cell-derived exosomes, Intranasal delivery, Traumatic Brain Injury, Hypoxic-Ischemic Encephalopathy, Neurologic Disorders, Real-world evidence, Stem cell therapy, Exosome therapy, Neuroregeneration, Regenerative medicine, Kurve Therapeutics, ViaNase, HIE, Cerebral Palsy, stroke, Multiple Sclerosis, Alzheimers Dementia, Parkinson Disease, Autism
Medical subject headings
Brain Injuries, Traumatic, Cerebral Palsy, Hypoxia-Ischemia, Brain, Nervous System Diseases, Multiple Sclerosis, Alzheimer Disease, Parkinson Disease, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07521384
Study groupRoleWhat they receive
MuSE Cell Derived ExosomesParticipants in this observational cohort receive MuSE cell derived exosomes administered intranasally via the Kurve Therapeutics ViaNase system as part of routine clinical care outside the study protocol. The study does not assign treatment. Participants are followed prospectively to evaluate safety and tolerability and to assess changes in serum tumor necrosis factor alpha (TNF-α) as a biomarker of systemic inflammation. Exploratory outcomes include changes in neurologic function, symptom burden, and health-related quality of life over time.
MuSE Stem CellsParticipants in this observational cohort receive MuSE stem cells administered intranasally via the Kurve Therapeutics ViaNase system as part of routine clinical care outside the study protocol. The study does not assign treatment. Participants are followed prospectively to evaluate safety and tolerability and to assess changes in serum tumor necrosis factor alpha (TNF-α) as a biomarker of systemic inflammation. Exploratory outcomes include changes in neurologic function, symptom burden, and health-related quality of life over time.
Combination MuSE Exosomes Plus MuSE Stem CellsParticipants in this observational cohort receive combination therapy consisting of MuSE cell derived exosomes and MuSE stem cells administered intranasally via the Kurve Therapeutics ViaNase system as part of routine clinical care outside the study protocol. The study does not assign treatment. Participants are followed prospectively to evaluate safety and tolerability and to assess changes in serum tumor necrosis factor alpha (TNF-α) as a biomarker of systemic inflammation. Exploratory outcomes include changes in neurologic function, symptom burden, and health-related quality of life over time.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Serum Tumor Necrosis Factor Alpha (TNF-α) From Baseline to 1 Month

    Serum TNF-α concentration in pg/mL measured at baseline before treatment and at 1 month after treatment; analyzed as absolute and percent change from baseline within and across treatment cohorts.

    Measured: Baseline to 1 Month

  2. Incidence of Adverse Events

    Number of participants with treatment-emergent adverse events after intranasal administration, categorized by seriousness, severity, and relationship to treatment as assessed from available clinical documentation.

    Measured: Baseline to 6 Months

Secondary outcomes (4)

  1. Change in Serum TNF-α From Baseline to 3 Months

    Change in serum TNF-α concentration from baseline to 3 months following intranasal therapy, analyzed by treatment cohort.

    Measured: Baseline to 3 Months

  2. Caregiver or Participant Global Impression of Change

    Caregiver- or participant-reported overall change in condition compared with baseline using a 7 point global impression of change scale.

    Measured: Baseline to 3 Months

  3. Change in Health Related Quality of Life

    Change in health related quality of life from baseline using the Pediatric Quality of Life Inventory (PedsQL) for pediatric participants or a comparable age appropriate quality of life instrument for adult participants.

    Measured: Baseline to 3 Months

  4. Change in Diagnosis Specific Functional Outcome Measures

    Change from baseline in diagnosis appropriate validated functional measures, including GMFM-66 for cerebral palsy, GOSE for traumatic brain injury, modified Rankin Scale for stroke, and other predefined condition-specific instruments where applicable.

    Measured: Baseline to 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion30 Jan 2029 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07521384
Sponsor's protocol ID
HHI-MUSE-OBS-2026-001
Acronym
MuSE-INSIGHT
Status last verified
Apr 2026
First submitted
3 Apr 2026
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De identified individual participant data (IPD), including demographic information, treatment details, and outcome measures such as TNF-α levels and clinical assessments, may be shared with qualified researchers upon reasonable request. Data will be shared only after removal of all direct identifiers and in compliance with applicable privacy regulations. Data access will be provided for purposes of scientific research, analysis, and publication, subject to approval by the study sponsor or designated review body. Additional documentation, including study protocol and statistical analysis plans, may be made available upon request. No data will be shared that could compromise participant confidentiality or violate applicable regulatory or ethical standards.

Publications

  • Lu Z, Ren S, Wang B, Shao L, Zhang Y, Wu H, Mu X, Wang Z. Intranasally administered muse cells attenuate neurodegeneration in Parkinson's disease. J Transl Med. 2025 Dec 24;23(1):1421. doi: 10.1186/s12967-025-07401-6.

    PubMed 41444595

  • Perone MJ, Gimeno ML, Fuertes F. Immunomodulatory Properties and Potential Therapeutic Benefits of Muse Cells Administration in Diabetes. Adv Exp Med Biol. 2018;1103:115-129. doi: 10.1007/978-4-431-56847-6_6.

    PubMed 30484226

  • Yamada Y, Minatoguchi S, Baba S, Shibata S, Takashima S, Wakao S, Okura H, Dezawa M, Minatoguchi S. Human Muse cells reduce myocardial infarct size and improve cardiac function without causing arrythmias in a swine model of acute myocardial infarction. PLoS One. 2022 Mar 24;17(3):e0265347. doi: 10.1371/journal.pone.0265347. eCollection 2022.

    PubMed 35324926

  • 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 27999136

  • Nagaoki T, Kumagai G, Nitobe Y, Sasaki A, Fujita T, Fukutoku T, Saruta K, Tsukuda M, Asari T, Wada K, Dezawa M, Ishibashi Y. Comparison of the Anti-Inflammatory Effects of Mouse Adipose- and Bone-Marrow-Derived Multilineage-Differentiating Stress-Enduring Cells in Acute-Phase Spinal Cord Injury. J Neurotrauma. 2023 Dec;40(23-24):2596-2609. doi: 10.1089/neu.2022.0470. Epub 2023 May 16.

    PubMed 37051701

  • Park YJ, Niizuma K, Mokin M, Dezawa M, Borlongan CV. Cell-Based Therapy for Stroke: Musing With Muse Cells. Stroke. 2020 Sep;51(9):2854-2862. doi: 10.1161/STROKEAHA.120.030618. Epub 2020 Aug 19.

    PubMed 32811374

  • Tanaka T, Nishigaki K, Minatoguchi S, Nawa T, Yamada Y, Kanamori H, Mikami A, Ushikoshi H, Kawasaki M, Dezawa M, Minatoguchi S. Mobilized Muse Cells After Acute Myocardial Infarction Predict Cardiac Function and Remodeling in the Chronic Phase. Circ J. 2018 Jan 25;82(2):561-571. doi: 10.1253/circj.CJ-17-0552. Epub 2017 Sep 20.

    PubMed 28931784

  • Hori E, Hayakawa Y, Hayashi T, Hori S, Okamoto S, Shibata T, Kubo M, Horie Y, Sasahara M, Kuroda S. Mobilization of Pluripotent Multilineage-Differentiating Stress-Enduring Cells in Ischemic Stroke. J Stroke Cerebrovasc Dis. 2016 Jun;25(6):1473-81. doi: 10.1016/j.jstrokecerebrovasdis.2015.12.033. Epub 2016 Mar 24.

    PubMed 27019988

  • Kuroda Y, Wakao S, Kitada M, Murakami T, Nojima M, Dezawa M. Isolation, culture and evaluation of multilineage-differentiating stress-enduring (Muse) cells. Nat Protoc. 2013;8(7):1391-415. doi: 10.1038/nprot.2013.076. Epub 2013 Jun 20.

    PubMed 23787896

  • 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.

    PubMed 31826733

  • Suzuki T, Sato Y, Kushida Y, Tsuji M, Wakao S, Ueda K, Imai K, Iitani Y, Shimizu S, Hida H, Temma T, Saito S, Iida H, Mizuno M, Takahashi Y, Dezawa M, Borlongan CV, Hayakawa M. Intravenously delivered multilineage-differentiating stress enduring cells dampen excessive glutamate metabolism and microglial activation in experimental perinatal hypoxic ischemic encephalopathy. J Cereb Blood Flow Metab. 2021 Jul;41(7):1707-1720. doi: 10.1177/0271678X20972656. Epub 2020 Nov 22.

    PubMed 33222596

  • Hori Y, Kitani T, Yanishi K, Suga T, Kogure M, Kusaba T, Kushida Y, Dezawa M, Matoba S. Intravenous administration of human Muse cells recovers blood flow in a mouse model of hindlimb ischemia. Front Cardiovasc Med. 2022 Nov 11;9:981088. doi: 10.3389/fcvm.2022.981088. eCollection 2022.

    PubMed 36440014

  • Chen X, Yin XY, Zhao YY, Wang CC, Du P, Lu YC, Jin HB, Yang CC, Ying JL. Human Muse cells-derived neural precursor cells as the novel seed cells for the repair of spinal cord injury. Biochem Biophys Res Commun. 2021 Sep 3;568:103-109. doi: 10.1016/j.bbrc.2021.06.070. Epub 2021 Jun 30.

    PubMed 34214874

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury and Cerebral Palsy, run by Healing Hope International at 1 site in Mexico.

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 5 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: enrolling by invitation, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum Tumor Necrosis Factor Alpha (TNF-α) From Baseline to 1 Month (time frame: Baseline to 1 Month). The study lists 2 primary outcomes in all. 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 NCT07521384, which also lists 13 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 9 Apr 2026.

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