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

NCT07521384 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Kurve Technology Inc.

    collaborator OTHER
  • Healing Hope International

    lead OTHER

Principal Investigators

  • Dr. Glen Cronett, PhD/MD · Kurve Therapeutics

Eligibility

Min Age
4 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-01-01
Completion
2029-01-30

Countries

  • Mexico

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07521384 on ClinicalTrials.gov