Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for NAION

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Non-arteritic Ischemic Optic Neuropathy

This trial will study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of non-arteritic ischemic optic neuropathy

This patient funded trial aims to study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of non-arteritic ischemic optic neuropathy. The total dose will be 100 million cells. 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.

Inclusion Criteria:

• Diagnosis of NAION (non-arteritic ischemic optic 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