An observational study in Traumatic Brain Injury, Cerebral Palsy and Hypoxic Ischemic Encephalopathy, sponsored by Healing Hope International. Enrolling by invitation at 1 site in Mexico. Open to participants aged 4 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Healing Hope International · Observational
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.
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.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 36 is below the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Healing Hope International is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
Time frame: Baseline to 1 Month
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.
Time frame: Baseline to 6 Months
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.
Time frame: Baseline to 3 Months
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.
Time frame: Baseline to 3 Months
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.
Time frame: Baseline to 3 Months
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.
Time frame: Baseline to 3 Months
Change in Gross Motor Function Measure-66 Score in Participants With Cerebral Palsy
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.
Time frame: Baseline to 3 Months
Change in Glasgow Outcome Scale-Extended Score in Participants With Traumatic Brain Injury
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.
Time frame: Baseline to 3 Months
Change in Modified Rankin Scale Score in Participants With Stroke
Global disability will be assessed using the modified Rankin Scale, a 0 to 6 ordinal scale in which lower scores indicate less disability.
Time frame: Baseline to 3 Months
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
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.
Start is estimated for Jun 2026; primary completion for Jan 2028, 19 months later.
Of 228 non-industry observational studies under Brain Injuries, Traumatic, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 95. This study's planned 19 months is below that.
Counting every sponsor, half of 250 studies reached it within 49 months; a quarter within 23 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
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Healing Hope International