safety assessment of intravitreal mesenchymal stem cells for acute non arteritic anterior ischemic optic neuropathy

Conditions: Non Arteritic Ischemic Optic Neuropathy

Summary: 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.


Eligibility criteria:
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

Keywords: acute non arteritic anterior ischemic optic neuropathy mesenchymal stem cells intravitreal injection safety