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

Primary Purpose

Non Arteritic Ischemic Optic Neuropathy

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
intravitreal injection of MSV
Sponsored by
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Arteritic Ischemic Optic Neuropathy focused on measuring acute non arteritic anterior ischemic optic neuropathy, mesenchymal stem cells, intravitreal injection, safety

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IOBA - Applied Ophthalmobiology Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mesenchymal stem from valladolid (MSV)

Arm Description

Allogenic mesenchymal stem cells from bone marrow

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 24, 2017
Last Updated
April 5, 2021
Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborators
University of Valladolid
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1. Study Identification

Unique Protocol Identification Number
NCT03173638
Brief Title
Safety Assessment of Intravitreal Mesenchymal Stem Cells for Acute Non Arteritic Anterior Ischemic Optic Neuropathy
Acronym
NEUROSTEM
Official Title
Phase II Safety Assessment of Intravitreal Injection of Mesenchymal Stem Cells for Acute Non Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborators
University of Valladolid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Arteritic Ischemic Optic Neuropathy
Keywords
acute non arteritic anterior ischemic optic neuropathy, mesenchymal stem cells, intravitreal injection, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stem from valladolid (MSV)
Arm Type
Experimental
Arm Description
Allogenic mesenchymal stem cells from bone marrow
Intervention Type
Procedure
Intervention Name(s)
intravitreal injection of MSV
Intervention Description
A unique intravitreal injection of MSV in acute fase of NAION
Primary Outcome Measure Information:
Title
Absence of inflammatory reaction - Slit lamp exploration - SUN (Standardization of Uveitis Nomenclature) scale
Description
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
Time Frame
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 Measure Information:
Title
Adverse events procedure-related (intravitreal injection)
Description
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
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José C Pastor Jimeno, MD, PhD
Organizational Affiliation
IOBA-UVA
Official's Role
Principal Investigator
Facility Information:
Facility Name
IOBA - Applied Ophthalmobiology Institute
City
Valladolid
ZIP/Postal Code
47011
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-003029-40/ES
Description
European Union Clinical Trials Register

Learn more about this trial

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

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