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Therapy of Toxic Optic Neuropathy Via Combination of Stem Cells With Electromagnetic Stimulation

NCT04877067 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-05-10

No results posted yet for this study

Summary

The axons of the retinal ganglion cells combine to form the optic nerve. The optic nerve transmits electrical signals to the visual cortex by various synapses. Optic nerve axons are more sensitive to toxins than retina because they are outside the blood retinal barrier. Methanol, various solvents and heavy metals, carbon dioxide, antiarrhythmic, antiepileptic, antibiotics and some vasoactive drugs can cause toxic optic neuropathy. There is a different pathophysiology for each toxin. Methanol is easily accessible alcohol in all types of disinfectants. Methanol is converted into formaldehyde and formic acid while metabolized in the liver. Formaldehyde disrupts ATP synthesis by blocking mitochondrial function and oxidative phosphorylation. Formic acid causes demyelination as a result of metabolic acidosis. Neuroinflammation occurs when denatured proteins block axoplasmic flow. All these processes can lead to apoptosis and permanent vision loss. Sildenafil is a vasoactive drug used in erectile dysfunction. Sildenafil decreases optic nerve head blood flow. Neuroinflammation develops secondary to the cessation of axoplasmic flow after hypoxia. If hypoxia and neuroinflammatiom persists, apoptosis and permanent vision loss develop. Amiodarone is an ion channel blocker used in the treatment of cardiac arrhythmias. Long-term use may cause disruption of ion channel balance in the optic nerve. This condition leads to asymmetric neuroinflammation and apoptosis.

Wharton's jelly derived mesenchymal stem cells (WJ-MSC) can increase mitochondrial ATP synthesis with paracrine effects and suppress neuroinflammation with immunomodulatory effects. Repetitive electromagnetic stimulation (rEMS) can rearrange ion channel balances and axoplasmic flow. The aim of this prospective phase-3 clinical study is to investigate the effect of WJ-MSC and rEMS combination in the therapy of toxic optic neuropathies. This combination is the first study in the literature for the therapy of toxic optic neuropathies.

Conditions

  • Methanol Poisoning
  • Toxic Optic Neuropathy
  • Stem Cell Tyrosine Kinase 1 Y842X
  • Magnetic Field Exposure

Interventions

BIOLOGICAL

Wharton jelly derived mesenchymal stem cell

WJ-MSC

DEVICE

Repetitive electromagnetic stimulation

rEMS

Sponsors & Collaborators

  • International Olympic Committee

    collaborator UNKNOWN

  • Ankara Universitesi Teknokent

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04877067 on ClinicalTrials.gov