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

Phase 1

Recruiting

• Conditions: Trigeminal Neuralgia; Peripheral Neuropathy
• Interventions: Biological: AlloRx; Biological: AlloEx

• Registration Number: NCT05152368
• Lead Sponsor: The Foundation for Orthopaedics and Regenerative Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Study First Posted: 2021-12-09
• Study Start: 2022-09-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group (AlloRx)	AlloRx	Single intravenous infusion of 100 million cells
Treatment Group (AlloEx)	AlloEx	Intranasal installation of 4 CCs of AlloEx, which is approximately 800 billion exosomes.

Primary Outcome Measures

Name	Time	Method
Safety (adverse events)	Four year follow-up	Clinical monitoring of possible adverse events or complications

Trial Locations

Locations (1)

Medical Surgical Associates Center; 🇦🇬 St. John's, Antigua and Barbuda