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ENROLLING BY INVITATION
NCT07521384

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

Sponsor: Healing Hope International

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

4 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

36

Start Date

2026-06-01

Completion Date

2029-01-30

Last Updated

2026-04-09

Healthy Volunteers

No

Locations (1)

Stem Solutions

Monterrey, Nuevo León, Mexico