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.