NCT03173638

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Arteritic Ischemic Optic Neuropathy

Interventions

Type	Name	Description
PROCEDURE	intravitreal injection of MSV	A unique intravitreal injection of MSV in acute fase of NAION

Timeline

• Start date: 2018-03-23
• Primary completion: 2022-04-01
• Completion: 2022-12-01
• First posted: 2017-06-02
• Last updated: 2021-04-06

Locations

1 site across 1 country: Spain