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Safety and Outcomes of MUSE Stem Cell Therapy in Individuals With Traumatic Brain Injury

NCT07326059 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2026-03-10

No results posted yet for this study

Summary

This prospective observational study evaluates the safety profile and patient-reported outcomes associated with MUSE (Multilineage-differentiating Stress-Enduring) stem cell therapy in individuals aged 6 to 75 with chronic traumatic brain injury (TBI). Participants independently elect to receive MUSE cell treatment through international clinical programs, and this study aims to capture real-world evidence on the potential therapeutic effects and risks of this emerging regenerative approach.

The study does not administer any intervention. Instead, it follows participants who have received, or plan to receive, MUSE cell infusions outside the United States. Over a 12-month follow-up period, data will be collected on neurological functioning, quality of life, activities of daily living, and any reported adverse events or complications. Information will be gathered through remote interviews, structured digital surveys, and review of medical documentation when available.

This research is sponsored by Healing Hope International and is intended to contribute to the ethical and responsible advancement of novel cell-based therapies by generating real-world evidence that may guide future clinical trial development and inform patient care practices.

Conditions

  • Traumatic Brain Injury
  • Traumatic Brain Injury (TBI) Patients
  • Traumatic Brain Injury (TBI); Concussion, Initial Encounter
  • Traumatic Brain Injury (TBI); Concussion, Subsequent Encounter
  • Traumatic Brain Injury With Brief Loss of Consciousness
  • Traumatic Brain Injury With Persistent Cognitive Deficits

Interventions

BIOLOGICAL

MUSE Stem Cell Therapy

MUSE (Multilineage-differentiating Stress-Enduring) stem cell therapy refers to the use of a naturally occurring subpopulation of mesenchymal lineage cells characterized by stress tolerance, expression of SSEA-3, and the capacity to differentiate into multiple cell types. Preclinical studies have shown that MUSE cells can migrate to sites of tissue injury, including the central nervous system, and may contribute to tissue repair through paracrine and regenerative mechanisms. In this observational study, participants independently obtain MUSE stem cell therapy at licensed treatment facilities outside the United States as part of their personal medical care. The study team does not provide, administer, manufacture, or direct the therapy.

Sponsors & Collaborators

  • Healing Hope International

    lead OTHER

Principal Investigators

  • Dr. Lambert Abeyatunge, MD: Regenerative Medicine

Eligibility

Min Age
6 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2028-01-31
Primary Completion
2034-12-31
Completion
2036-06-30

Countries

  • United States
  • Mexico

Study Locations

More Related Trials

Entities

Diseases

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 NCT07326059 on ClinicalTrials.gov