In this study the investigators propose to perform a Phase II Clinical Trial which seeks to evaluate the safety of cell therapy as a new treatment for patients who suffer from acute non-arteritic anterior ischemic optic neuropathy (NAION). If it is successful, a later study to assess efficacy will be performed.

This disease has an age-adjusted incidence rate of 10/100.000, and in many cases it results in blindness. Currently, there is no available treatment and second eye involvement occurs in approximately 15-25% of the cases.

All this background originates a particularly dramatic outcome for the patient. Therefore, it seems justified to evaluate new therapies that maintain or improve the visual function in these patients.

The Project includes a clinical trial whose purpose is the assessment of the safety of intravitreal administration of allogenic mesenchymal stem cells (MSC) in patients with NAION, a product in clinical research phase (PEI No. 15-007) already approved for other human clinical applications (PEI No. 15-007).

It can be considered that the therapy with intravitreal injection of MSC is a treatment option in patients with acute NAION, since through the paracrine properties of these cells (secretion of neurotrophic, immunomodulatory and anti-apoptotic factors) it may prevent or reduce the progression of axonal degeneration caused by this disease.

Inclusion Criteria:

• Patients with acute unilateral NAION (within two weeks after the first symptoms) with at least two of the following:

  1. Sudden and unpainful monocular vision loss
  2. Visual field defects
  3. Dyschromatopsia.
  4. Ocular nerve head edema.
  5. Afferent relative pupil defect.

• Patients ≥ 50 years old, able to freely give informed consent.

• Best corrected visual acuity (BCVA) ≤ 0,1 in study eye.

• Pseudophakia in study eye.

• Preserved pupil sphincter muscle motility

• Signed informed consent form before any study procedure.

• Signed data protection consent form before any study procedure.

Exclusion Criteria:

• Giant cell arteritis evidence (clinical history, Erythrocyte sedimentation rate (ESR), C-Reactive Protein)
• Evidence of any other etiology that may justify the optic neuropathy (even in the non-study eye)
• History of systemic vasculitis, multiple sclerosis, collagenopathies or previous cancer treatments.
• Hypersensitivity or allergy to any compound used in the study, including investigational medicinal product (IMP).
• Positive pregnancy test at baseline
• Participation in any other research study within 2 months

Ophthalmic exclusion criteria

• History of uveitis or active ocular inflammation
• History or evidence of glaucoma or high intraocular pressure ( ≥ 24 mmHg in either eye).
• Mean opacities or retinal pathologies in the study eye.
• Any previous vitreous or glaucoma surgery in the study eye
• Cataract surgery within 3 months in the study eye