NCT05152368

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Foundation for Orthopaedics and Regenerative Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Neuropathy
• Trigeminal Neuralgia

Interventions

Type	Name	Description
BIOLOGICAL	AlloEx	cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes

Timeline

• Start date: 2022-09-09
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2021-12-09
• Last updated: 2025-04-17

Locations

1 site across 1 country: Antigua and Barbuda

Regulatory

• FDA-regulated drug study