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

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Status and phase

Unknown

Phase 2

Conditions

Non Arteritic Ischemic Optic Neuropathy

Treatments

Procedure: intravitreal injection of MSV

Study type

Interventional

Funder types

Other

Identifiers

NCT03173638

2016-003029-40 (EudraCT Number)

IOBA01-2016

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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