Observes people receiving nasal exosome or stem cell treatment for brain conditions
Follows people with brain or nerve conditions who receive intranasal MuSE exosomes or stem cells.
Plain-language title generated from the registry record
Registry title: Real World Outcomes of Intranasal MuSE Exosomes and Stem Cells in Neurological Regenerative Therapy
Key facts
- Where
- Monterrey, MexicoSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 4 and 80 years old?
Source: NCT07521384, who can take part
Where in Mexico
- Stem SolutionsMonterrey, MexicoNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Healing Hope International
- Trial code
- NCT07521384
- Record updated
- 9 April 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Use of systemic immunosuppressive or biologic anti-inflammatory therapies that may significantly alter TNF-α levels within 30 days prior to baseline measurement; Active systemic infection at the time of enrollment; Any medical condition that, in the opinion of the investigator, would interfere with interpretation of study outcomes; Inability to obtain baseline or follow-up TNF-α measurements; Incomplete documentation of treatment type, dose, or administration method.