June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Safety of intravitreal allogeneic mesenchymal stem cells for Acute Non-Arteritic Optic Neuropathy. Pilot study
Author Affiliations & Notes
  • Jose-Carlos Pastor
    Instituto de Oftalmobiologia Aplicada, Valladolid, Castilla y León, Spain
  • Salvador Pastor-Idoate
    Instituto de Oftalmobiologia Aplicada, Valladolid, Castilla y León, Spain
    Ophthalmology, Hospital Clinico Universitario, Valladolid, Valladolid, Spain
  • Marina Lopez-Paniagua
    Instituto de Oftalmobiologia Aplicada, Valladolid, Castilla y León, Spain
    Centro de Investigacion Biomedica en red en Bioingenieria Biomateriales y Nanomedicina, Madrid, Madrid, Spain
  • Marta Para
    Instituto de Oftalmobiologia Aplicada, Valladolid, Castilla y León, Spain
    Ophthalmology, Hospital Clinico Universitario, Valladolid, Valladolid, Spain
  • Francisco Blazquez
    Instituto de Oftalmobiologia Aplicada, Valladolid, Castilla y León, Spain
  • Esther Murgui
    Instituto de Oftalmobiologia Aplicada, Valladolid, Castilla y León, Spain
  • Rosa Coco-Martin
    Instituto de Oftalmobiologia Aplicada, Valladolid, Castilla y León, Spain
  • Footnotes
    Commercial Relationships   Jose-Carlos Pastor None; Salvador Pastor-Idoate None; Marina Lopez-Paniagua None; Marta Para None; Francisco Blazquez None; Esther Murgui None; Rosa Coco-Martin None
  • Footnotes
    Support   Strategic Action in Health of the Institute of Health Carlos III (PIC18/00018), the Department of Regional Health of the Castilla y Léon Government (GRS 1928/A/19), and the Department of Education of the Castilla y León Regional Government (Grant VA077P17).
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 4500 – F0287. doi:
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      Jose-Carlos Pastor, Salvador Pastor-Idoate, Marina Lopez-Paniagua, Marta Para, Francisco Blazquez, Esther Murgui, Rosa Coco-Martin; Safety of intravitreal allogeneic mesenchymal stem cells for Acute Non-Arteritic Optic Neuropathy. Pilot study. Invest. Ophthalmol. Vis. Sci. 2022;63(7):4500 – F0287.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To comunicate the results after 6 months of follow-up of a pilot clinical trial (CT), carried out in five patients, with Non-Arteritic Optic Neuropathy, in its acute phase, who received an intravitreal injection of allogeneic bone-marrow derived mesenchymal stem cells (MSV®-allo) during the first 15 days after acute event.

Methods : Prospective, non-randomized, phase I-IIa CT. (Eudra number 2016-003029-40 and Clinical Trial Registry NCT03173638). After verifying the inclusion criteria (patients ≧ 50 years old, with a vissual acuity less than 0,4 and at least two of the following characteristics: sudden and painless loss of monocular vision; optic nerve head edema; clear relative afferent pupillary defect and without evidence of giant cell arteritis through medical history, erythrocyte sedimentation rate, C-reactive protein)and exclusion criteria, and having signed the informed consent, patients received an intravitreal injection of 0.05 ml containing 150 µl of isotonic medium composed of Ringer-lactate + 0.5% human albumin + 5 mM glucose with a cell concentration of 1.5x10 6 cells / ml with a 25G needle via pars plana after topical anesthesia. Patients were followed at days 1, 7, 30, 90 and 180 after injection. Best corrected visual acuity, anterior and posterior pole examination searching for inflammatory signs. Pattern Reversal Visual Evoked Potential (PRVEP) and Flash Visual Evoked Potential (FVEP) and retinal nerve fiber layer (RNFL) and ganglion cell layer (GCL) thickness was assessed using a Spectral domain optical coherence tomograph (OCT).

Results : One patient developed an epiretinal membrane. Another one showed a retrolental aggregate that was not complicated with cataract progression. No signs of intraocular inflammation were detected in any patient. Most of them showed a clear visual improvement and all patients presented increase in the P2 amplitude on the FVEP. OCT results (RNFL and GCL thickness) showed a significant decrease in agreement with the visible papillary atrophy developed during the follow up.

Conclusions : Despite the appearance of an epiretinal membrane in one patient and a possible cellular deposit in retrolental space, the functional results are encouraging for further studies.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

 

Aggregate of mesemchymal stem cells in vitreous immediately after injection

Aggregate of mesemchymal stem cells in vitreous immediately after injection

 

Retrolental deposit after mesemchymal stem cells intravitreal injection

Retrolental deposit after mesemchymal stem cells intravitreal injection

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