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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
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
|Contact: Francisco Blazquez-Arauzo, MD||0034 email@example.com|
|Contact: Rosa Coco Martin, MD, PhD||0034 firstname.lastname@example.org|
|IOBA - Applied Ophthalmobiology Institute||Recruiting|
|Valladolid, Spain, 47011|
|Contact: Francisco Blazquez Arauzo, MD, MsC 34 983184734 email@example.com|
|Contact: José Carlos Pastor Jimeno, MD, PhD 34 983184734 firstname.lastname@example.org|
|Principal Investigator: Jose Carlos Pastor Jimeno, MD, PhD|
|Sub-Investigator: Rosa Coco Martín, MD, PhD|
|Sub-Investigator: Francisco Blazquez Arauzo, MD, MsC|
|Principal Investigator:||José C Pastor Jimeno, MD, PhD||IOBA-UVA|