Real World Outcomes of Intranasal MuSE Exosomes and Stem Cells in Neurological Regenerative Therapy (MuSE-INSIGHT)

April 3, 2026 updated by: Healing Hope International

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.

Study Overview

Status

Enrolling by invitation

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico
        • Stem Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MuSE Cell Derived Exosomes

Participants 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 Cells

Participants 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 Cells

Participants 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum Tumor Necrosis Factor Alpha (TNF-α) From Baseline to 1 Month
Time Frame: 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.
Baseline to 1 Month
Incidence of Adverse Events
Time Frame: Baseline to 6 Months
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.
Baseline to 6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum TNF-α From Baseline to 3 Months
Time Frame: Baseline to 3 Months
Change in serum TNF-α concentration from baseline to 3 months following intranasal therapy, analyzed by treatment cohort.
Baseline to 3 Months
Caregiver or Participant Global Impression of Change
Time Frame: Baseline to 3 Months
Caregiver- or participant-reported overall change in condition compared with baseline using a 7 point global impression of change scale.
Baseline to 3 Months
Change in Health Related Quality of Life
Time Frame: Baseline to 3 Months
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.
Baseline to 3 Months
Change in Diagnosis Specific Functional Outcome Measures
Time Frame: Baseline to 3 Months
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.
Baseline to 3 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gross Motor Function Measure-66 Score in Participants With Cerebral Palsy
Time Frame: Baseline to 3 Months
Gross motor function will be assessed in participants with cerebral palsy using the GMFM-66. Items are scored on a 4-point ordinal scale and summarized as a total score; higher scores indicate better gross motor function.
Baseline to 3 Months
Change in Glasgow Outcome Scale-Extended Score in Participants With Traumatic Brain Injury
Time Frame: Baseline to 3 Months
Global disability and recovery will be assessed using the Glasgow Outcome Scale-Extended, an 8-level ordinal scale in which higher scores indicate better recovery.
Baseline to 3 Months
Change in Modified Rankin Scale Score in Participants With Stroke
Time Frame: Baseline to 3 Months
Global disability will be assessed using the modified Rankin Scale, a 0 to 6 ordinal scale in which lower scores indicate less disability.
Baseline to 3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healing Hope International

Collaborators

Kurve Technology Inc.

Investigators

  • Principal Investigator: Dr. Glen Cronett, PhD/MD, Kurve Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 30, 2029

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHI-MUSE-OBS-2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Individual participant data and supporting documents will be made available beginning 6 months following completion of primary data collection and will remain available for a period of 5 years.

IPD Sharing Access Criteria

Access to de identified individual participant data will be provided to qualified researchers upon reasonable request. Requests must include a research proposal outlining the intended use of the data.

Access will be granted following review and approval by the study sponsor or designated review body and may require a data use agreement. Only de-identified data necessary for the approved research purpose will be shared.

Data will be provided in a secure manner that protects participant confidentiality and complies with applicable ethical and regulatory standards.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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