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

Sponsor
Healing Hope International
Study ID
NCT07521384
Status
Enrolling By Invitation

Conditions

  • Alzheimer Dementia (AD)
  • Autism
  • Cerebral Palsy
  • Hypoxic Ischemic Encephalopathy
  • MS (Multiple Sclerosis)
  • Neurologic Disorders
  • Parkinson Disease (PD)
  • Stroke
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
4 Years - 80 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Apr 9, 2026
Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jan 1, 2028
Completion
Jan 30, 2029

Study Design

Enrollment
36 participants (estimated)

Arms

  • Arm: MuSE Cell Derived Exosomes
    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.
  • Arm: MuSE Stem Cells
    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.
  • Arm: Combination MuSE Exosomes Plus MuSE Stem Cells
    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.

Primary Outcome Measure

Change in Serum Tumor Necrosis Factor Alpha (TNF-α) From Baseline to 1 Month [ Time Frame: Baseline to 1 Month ]

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