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

The Foundation for Orthopaedics and Regenerative Medicine

Status and phase

Enrolling

Phase 1

Conditions

Peripheral Neuropathy

Trigeminal Neuralgia

Treatments

Biological: AlloEx

Study type

Interventional

Funder types

Other

Identifiers

NCT05152368

ATG-1-MSC-019

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Volunteers

No 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