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Real World Outcomes of Intranasal MuSE Exosomes and Stem Cells in Neurological Regenerative Therapy

Enrolling By InvitationN/A

Sponsor: Healing Hope International

Conditions: Traumatic Brain Injury, Cerebral Palsy, Hypoxic Ischemic Encephalopathy, Neurologic Disorders, MS (Multiple Sclerosis)

Countries: Mexico

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.

Eligibility overview

Sex: ALL

Age: 4 Years to 80 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

Monterrey, Nuevo León, Mexico