Using stem cell exosomes to treat Trigeminal Neuralgia
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells Exosomes for the Treatment of Trigeminal Neuralgia
Run by The Foundation for Orthopaedics and Regenerative Medicine · NCT05152368 · Data updated 2026-11-12
This study is testing if a treatment using stem cell exosomes can help people with Trigeminal Neuralgia feel better and reduce their pain.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 2 sites (Naples, Florida and 1 other locations) |
| Status | Recruiting |
| Started | September 9, 2022 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT05152368 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with Trigeminal Neuralgia or Peripheral Neuropathy who are willing to provide informed consent.
✕Probably not a fit
Patients with active infections, cancer, or other significant health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the safety and efficacy of cultured allogeneic adult umbilical cord-derived mesenchymal stem cell exosomes for treating Trigeminal Neuralgia. Participants will receive an intranasal instillation of these exosomes, with a total dose of approximately 800 billion exosomes administered through both nasal cavities. Patients will be monitored for safety and efficacy at multiple time points over a period of up to four years. For those with more severe symptoms, an additional treatment using their own activated lymphocytes will be provided.
Why it matters
Potential benefit: If successful, this treatment could offer a novel and effective option for patients suffering from Trigeminal Neuralgia.
How similar studies have gone: While the use of stem cell exosomes is a relatively novel approach, similar studies have shown promise in other conditions, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Prodromos Stem Cell Institute
Naples, Florida, United States Recruiting -
Prodromos Stem Cell Institute
Athens, Greece Recruiting
Study contacts
- Principal investigator: Chadwick Prodromos, MD — The Foundation for Orthopaedics and Regenerative Medicine
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.