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

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.

NCT Number	NCT07521384
Lead Sponsor	Healing Hope International Collaborators: Kurve Technology Inc.
Conditions	Traumatic Brain Injury, Cerebral Palsy, Hypoxic Ischemic Encephalopathy, Neurologic Disorders, MS (Multiple Sclerosis), Alzheimer Dementia (AD), Parkinson Disease (PD), Stroke +1 more
Enrollment	36 participants
Start Date	2026-06-01
Primary Completion	2028-01-01 (estimated)
Study Completion	2029-01-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-09