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Tiny study to watch MUSE stem cells in brain injury patients seeking treatment abroad

NCT ID NCT07326059

Knowledge-focused Sponsor: Healing Hope International Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will follow 10 people aged 6 to 75 with chronic traumatic brain injury who choose to get MUSE stem cell therapy outside the U.S. Researchers will not give any treatment but will track safety, brain function, and quality of life for 12 months. The goal is to gather real-world information that could guide future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MUSE stem cells
What this could lead to
If results are promising, this could point toward a larger trial to test whether MUSE stem cells help repair brain damage from TBI.
What could go wrong
This is a very small observational study (10 people) with no control group, so it cannot prove the therapy works. Participants seek treatment abroad, which may have variable quality and safety standards.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2028

An estimate. Start dates often move.

Expected to finish

Jun 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study population consists of individuals aged 6 to 75 with chronic traumatic brain injury who independently choose to receive MUSE stem cell therapy at licensed medical facilities outside the United States. Participants represent a real-world cohort seeking regenerative treatment as part of their personal medical care. The study does not administer therapy but follows these individuals longitudinally to document safety signals, functional outcomes, quality-of-life measures, and health care utilization over a 12-month period. Data are collected through remote assessments, participant-provided medical documentation, and available clinical records.

Ages

6 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Individuals aged 6 to 75 years at the time of enrollment. Documented history of traumatic brain injury (TBI) occurring at least 6 months prior to enrollment (chronic phase). Participant has independently elected to receive MUSE (Multilineage-differentiating Stress-Enduring) stem cell therapy at a licensed treatment facility outside the United States. Ability of the participant or legally authorized representative to provide informed consent for participation in an observational study. Willingness to participate in remote or in-person follow-up assessments for up to 12 months. Ability to provide medical records, laboratory reports, or treatment documentation when available. Exclusion Criteria: Individuals who have not received, and do not plan to receive, MUSE cell therapy as part of their independent medical care. Inability or unwillingness to complete study assessments (e.g., severe communication barriers not manageable through caregiver assistance or technology). Any condition that, in the opinion of the study team, would make participation in an observational registry unsafe or infeasible (e.g., inability to provide minimal required data). Planned participation in another research study that would prevent collection of observational outcomes for this registry. Individuals currently incarcerated or in institutional settings where research participation is restricted. \-

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Conditions

The condition(s) this trial relates to.

Brain Concussion Brain Injuries, Traumatic brain injury dementia pugilistica traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Healing Hope International

    Houston, Texas, 77386, United States

  • Stem Solutions

    Monterrey, Nuevo León, 66278, Mexico

More trials for these conditions

Other studies related to the condition(s) this trial covers.