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

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ClinicalTrials.gov Identifier: NCT03173638
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : November 19, 2018
Sponsor:
Collaborator:
University of Valladolid
Information provided by (Responsible Party):
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

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.


Condition or disease Intervention/treatment Phase
Non Arteritic Ischemic Optic Neuropathy Procedure: intravitreal injection of MSV Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Safety Assessment of Intravitreal Injection of Mesenchymal Stem Cells for Acute Non Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: Mesenchymal stem from valladolid (MSV)
Allogenic mesenchymal stem cells from bone marrow
Procedure: intravitreal injection of MSV
A unique intravitreal injection of MSV in acute fase of NAION




Primary Outcome Measures :
  1. Absence of inflammatory reaction - Slit lamp exploration - SUN (Standardization of Uveitis Nomenclature) scale [ 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 ]
    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 :
  1. Adverse events procedure-related (intravitreal injection) [ 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 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173638


Contacts
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Contact: Francisco Blazquez-Arauzo, MD 0034 983184734 blazquez@ioba.med.uva.es
Contact: Rosa Coco Martin, MD, PhD 0034 983184734 rosa@ioba.med.uva.es

Locations
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Spain
IOBA - Applied Ophthalmobiology Institute Recruiting
Valladolid, Spain, 47011
Contact: Francisco Blazquez Arauzo, MD, MsC    34 983184734    blazquez@ioba.med.uva.es   
Contact: José Carlos Pastor Jimeno, MD, PhD    34 983184734    pastor@ioba.med.uva.es   
Principal Investigator: Jose Carlos Pastor Jimeno, MD, PhD         
Sub-Investigator: Rosa Coco Martín, MD, PhD         
Sub-Investigator: Francisco Blazquez Arauzo, MD, MsC         
Sponsors and Collaborators
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
University of Valladolid
Investigators
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Principal Investigator: José C Pastor Jimeno, MD, PhD IOBA-UVA

Additional Information:
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Responsible Party: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
ClinicalTrials.gov Identifier: NCT03173638     History of Changes
Other Study ID Numbers: IOBA01-2016
2016-003029-40 ( EudraCT Number )
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA:
acute non arteritic anterior ischemic optic neuropathy
mesenchymal stem cells
intravitreal injection
safety

Additional relevant MeSH terms:
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Ischemia
Peripheral Nervous System Diseases
Optic Nerve Diseases
Optic Neuritis
Optic Neuropathy, Ischemic
Pathologic Processes
Neuromuscular Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases