Using stem cell exosomes to treat Trigeminal Neuralgia
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells Exosomes for the Treatment of Trigeminal Neuralgia
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 |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 1 site (St John's) |
| Trial ID | NCT05152368 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Trigeminal Neuralgia or Peripheral Neuropathy who are willing to provide informed consent.
Not a fit: Patients with active infections, cancer, or other significant health issues may not benefit from this study.
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 performed: While the use of stem cell exosomes is a relatively novel approach, similar studies have shown promise in other conditions, indicating potential for success.
Eligibility criteria
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 this trial is running
St John's
- Medical Surgical Associates Center — St John's, Antigua and Barbuda (Recruiting)
Study contacts
- Principal investigator: Chadwick Prodromos, MD — The Foundation for Orthopaedics and Regenerative Medicine
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.