NCT07521384Enrolling by invitation
Real World Outcomes of Intranasal MuSE Exosomes and Stem Cells in Neurological Regenerative Therapy
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
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 36 (estimated)
- First submitted
- 3 Apr 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- Healing Hope International
- Diseases
- Stroke, Autism, Alzheimer disease, Parkinson disease, Multiple sclerosis
- NCT number
- NCT07521384
What you commit to
- Study type: Observational
- Planned participants: 36
- From 1 Jun 2026 to the primary completion date, 1 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of systemic immunosuppressive or biologic anti-inflammatory therapies that may significantly alter TNF-α levels within 30 days prior to baseline measurement
Other illness
- 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
Other
- Inability to obtain baseline or follow-up TNF-α measurements
- Incomplete documentation of treatment type, dose, or administration method
Who the study is looking for
- 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
Age in the registry: 4 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stem Solutions Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.