RT info:eu-repo/semantics/article
T1 Intravitreal allogeneic mesenchymal stem cells: a non-randomized phase II clinical trial for acute non-arteritic optic neuropathy
A1 Pastor Jimeno, José Carlos
A1 Pastor Idoate, Salvador
A1 López Paniagua, Marina
A1 Para Prieto, Marta
A1 Blázquez Araúzo, Francisco
A1 Murgui Tejedor, Esther
A1 García, Verónica
A1 Coco Martín, Rosa María
K1 NA-AION, Acute anterior ischemic optic neuropathy, MSV®, Allogeneic bone marrow-derived mesenchymal stem cells, BM-MSCs, Bone marrow mesenchymal stem cells
K1 3201.09 Oftalmología
AB ABSTRACT. BACKGROUND: An effective treatment for acute non-arteritic ischemic optic neuropathy (NA-AION) has not been known or proven yet. Previous studies have suggested a neuroprotective effect of allogeneic bone marrow-derived mesenchymal stem cells. This study aims to report the results of a clinical trial on patients with acute non-arteritic optic neuropathy (NA-AION) treated with an intravitreal injection of allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) (MSV®). METHODS: We conducted a prospective, non-randomized, clinical phase-II study (Eudra CT number 2016-003029-40; ClinicalTrials.gov Registry NCT03173638) that included 5 patients with acute unilateral NA-AION diagnosed within 2 weeks after symptom onset and who received an intravitreal injection of allogeneic BM-MSCs (0.05 ml; cell concentration: 1.5 × 106cells/mL). The patients underwent regular ophthalmological examinations and were followed for one year. RESULTS: In this trial, allogeneic BM-MSCs appeared to be safe as no patients developed signs of acute nor chronic intraocular inflammation or a significant change in intraocular pressure, although an epiretinal membrane was developed in one patient. A retrolental aggregate formed shortly after the injection spontaneously disappeared within a few weeks in another phakic patient, leaving a subcapsular cataract. Visual improvement was noted in 4 patients, and amplitudes of P100 on the visually evoked potentials recordings increased in three patients. The retinal nerve fiber layer and macular ganglion cell layer thicknesses significantly decreased during the follow-up. CONCLUSIONS Besides the development of an epiretinal membrane in one patient, the intravitreal application of allogeneic BM-MSCs appeared to be intraocularly well tolerated. Consequently, not only NA-AION but also BM-MSCs deserve more clinical investigational resources and a larger randomized multicenter trial that would provide stronger evidence both about safety and the potential therapeutic efficacy of intravitreally injected allogeneic BM-MSCsin acute NA-AION. TRIAL REGISTRATION: Safety Assessment of Intravitreal Mesenchymal Stem Cells for Acute Non-Arteritic Anterior Ischemic Optic Neuropathy (NEUROSTEM). NCT03173638. Registered June 02, 2017 https:// clini caltr ials. gov/ ct2/ show/ NCT03173638.
PB BMC Part of Springer Nature
SN 1757-6512
YR 2023
FD 2023-09-21
LK https://uvadoc.uva.es/handle/10324/68991
UL https://uvadoc.uva.es/handle/10324/68991
LA eng
NO Stem Cell Res Ther. 21 Sept 2023, vol. 14, n. 1, Article  number: 261, 12 páginas.
NO Producción Científica
DS UVaDOC
RD 27-jul-2024