NCT05152368

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

September 9, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

3.3 years

First QC Date

November 29, 2021

Last Update Submit

April 15, 2025

Conditions

Peripheral NeuropathyTrigeminal Neuralgia

Keywords

Peripheral NeuropathyTrigeminal Neuralgiastem cell treatment

Outcome Measures

Primary Outcomes (1)

  • Safety (adverse events)

    Clinical monitoring of possible adverse events or complications

    Four year follow-up

Study Arms (1)

Treatment Group (AlloEx)

EXPERIMENTAL

Intranasal installation of 4 CCs of AlloEx, which is approximately 800 billion exosomes.

Biological: AlloEx

Interventions

AlloExBIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes

Treatment Group (AlloEx)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Trigeminal Neuralgia or Peripheral Neuropathy
  • Understanding and willingness to sign a written informed consent document

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System DiseasesTrigeminal Neuralgia

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesTrigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve Diseases

Study Officials

  • Chadwick Prodromos, MD

    The Foundation for Orthopaedics and Regenerative Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 9, 2021

Study Start

September 9, 2022

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

AN(1)