New study observes patients getting nasal stem cell therapy for brain conditions
NCT ID NCT07521384
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This observational study follows 36 people with neurologic conditions like traumatic brain injury, cerebral palsy, multiple sclerosis, or Alzheimer's who are already receiving intranasal MuSE stem cell or exosome therapy as part of their routine care. Researchers track safety and changes in a key inflammation marker (TNF-α) over time. The goal is to gather real-world data on how these regenerative treatments affect the body, not to test a new drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MuSE cell derived exosomes, MuSE stem cells, or combination therapy delivered intranasally via the ViaNase device
- What this could lead to
- If successful, this study could provide early evidence on whether these regenerative therapies are safe and reduce inflammation in the brain, pointing toward future treatments for conditions like traumatic brain injury, multiple sclerosis, and Alzheimer's.
- What could go wrong
- This is a small, early observational study (36 participants) that does not assign treatment or compare against a placebo. Results may not prove effectiveness or apply to broader populations. Risks include unknown side effects from the intranasal delivery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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4 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stem Solutions
Monterrey, Nuevo León, Mexico
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