Safety Assessment of Intravitreal Mesenchymal Stem Cells for Acute Non Arteritic Anterior Ischemic Optic Neuropathy

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Safety Assessment of Intravitreal Injection of Mesenchymal Stem Cells for Acute Non Arteritic Anterior Ischemic Optic Neuropathy (NAION)

Conditions
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Non Arteritic Ischemic Optic Neuropathy

Intervention / Treatment
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* Procedure: intravitreal injection of MSV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute unilateral NAION (within two weeks after the first symptoms) with at least two of the following: Sudden and unpainful monocular vision loss Visual field defects Dyschromatopsia. Ocular nerve head edema. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem from valladolid (MSV)<br>Allogenic mesenchymal stem cells from bone marrow | Procedure: intravitreal injection of MSV<br>* A unique intravitreal injection of MSV in acute fase of NAION<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of inflammatory reaction - Slit lamp exploration - SUN (Standardization of Uveitis Nomenclature) scale | Following the SUN scale, the parameters that will be taken into account in the slit lamp exploration will be: cells and flare in anterior chamber, and vitreous flare | Changes compared to baseline in visits V1 (1day), V2 (1week), V3 (1 month), V4 (3 months), V5 (6 months) and V6 (12months) and in any unscheduled visit any patient might need | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events procedure-related (intravitreal injection) | Conjunctival haemorrhages, anterior chamber inflammation, changes in intraocular pressure, infectious endophthalmitis, vitreous inflammation, retinal detachment, choroidal detachment, corneal opacities, lens opacities, neovascularization, macular edema or any other adverse event that may appear | Throughout the study after treatment in visits V1 (1day), V2 (1week), V3 (1 month), V4 (3 months), V5 (6 months) and V6 (12months) and in any unscheduled visit any patient might need | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute non arteritic anterior ischemic optic neuropathy, mesenchymal stem cells, intravitreal injection, safety