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Can tiny cell particles calm a fiery facial nerve?

NCT ID NCT05152368

Symptom relief Sponsor: The Foundation for Orthopaedics and Regenerative Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time

Summary

Researchers are testing whether exosomes, tiny particles released by donor umbilical cord or placental stem cells, are safe and can help people with trigeminal neuralgia or peripheral neuropathy. The trial enrolls about 20 adults with a confirmed diagnosis. Participants receive the exosome product, and doctors monitor them for side effects and changes in nerve pain. The goal is to learn whether this cell-free approach is tolerable and worth studying further.

What this could mean

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

Active substance
exosomes derived from cultured donor umbilical cord or placental mesenchymal stem cells
What this could lead to
If it works, this could point toward a new cell-free treatment for trigeminal neuralgia and other nerve pain that does not rely on daily drugs or surgery.
What could go wrong
This is a small, early-stage safety trial, so it may show only whether the approach is tolerable, not whether it relieves pain. Donor-derived products can trigger immune reactions, and any benefit may not last or may not generalize to all patients.

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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

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

Started

Sep 2022

Expected to finish

Jan 2028

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Diagnosis of Trigeminal Neuralgia or Peripheral Neuropathy * Understanding and willingness to sign a written informed consent document Exclusion Criteria: * Active infection * Active cancer * Chronic multisystem organ failure * Pregnancy * Clinically significant Abnormalities on pre-treatment laboratory evaluation * Medical condition that would (based on the opinion of the investigator) compromise patient's safety. * Continued drug abuse * Pre-menopausal women not using contraception * Previous organ transplant * Hypersensitivity to sulfur

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Conditions

The condition(s) this trial relates to.

peripheral nervous system disorder peripheral neuropathy trigeminal neuralgia

As listed by the trial registrant

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

Peripheral neuropathy Trigeminal neuralgia

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

  • Prodromos Stem Cell Institute

    RECRUITING

    Naples, Florida, 34102, United States

  • Prodromos Stem Cell Institute

    RECRUITING

    Athens, Greece

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