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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Medical Surgical Associates Center
St John's, Antigua and Barbuda
RECRUITINGCenter for Investigation in Tissue Engineering and Cellular Therapy
Buenos Aires, Argentina
RECRUITINGSafety (adverse events)
Clinical monitoring of possible adverse events or complications
Time frame: Four year follow-up
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