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RECRUITINGPHASE1

Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells Exosomes for Trigeminal Neuralgia

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells Exosomes for the Treatment of Trigeminal Neuralgia

NCT05152368•The Foundation for Orthopaedics and Regenerative Medicine

View on ClinicalTrials.gov

Summary

This trial will study the safety and efficacy of instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of Trigeminal Neuralgia.

Detailed Description

This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (UC-MSCs) exosomes for the treatment of Trigeminal Neuralgia. Patients will receive an intranasal instillation of UC-MSCs exosomes. The total dose will be approximately 800 billion exosomes split evenly between both nasal cavities via Tian Syringe through 4 CCs of AlloEx. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy. For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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

Locations (1)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

Key Dates

Start Date

September 9, 2022

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2026

Last Updated

April 17, 2025

Enrollment

ESTIMATED participants

Conditions

Peripheral NeuropathyTrigeminal Neuralgia

Interventions

AlloEx

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells Exosomes for Trigeminal Neuralgia

Inclusion Criteria

Exclusion Criteria

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