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Rafael Arcieri, Katharina Messias, Vinicius Castro, Rubens Siqueira, Rodrigo Jorge, Andre Messias; Intravitreal Autologous Bone-Marrow Stem Cells in Retinitis Pigmentosa Patients: One-Year Results. Invest. Ophthalmol. Vis. Sci. 2013;54(15):643.
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To evaluate the effects of a single intravitreal injection of autologous bone-marrow stem cells (ABMSC) in Retinitis Pigmentosa (RP) patients.
A prospective, single blind, phase II, nonrandomized clinical trial, including 20 RP patients showing good fixation during visual field examination. Intravitreal ABMSC injection was performed in the study eye, while the contralateral eye served as control, and underwent sham procedure. Evaluations included best-correct visual acuity (BCVA), static 30-2 visual field (Octopus 900), microperimetry (MAIA - CenterVue) for fixation stability (BCEA), and macular sensitivity (AVTH) determination. Full-field and multifocal electroretinograms (ERG) were performed according to the ISCEV standards using Espion E2 (Diagnosys LLC). Examinations were performed at baseline, 4, 16, 32 and 48 weeks after injection.
No significant intra-individual (48 weeks - baseline) BCVA change was observed, with a slight improvement of -0.04 ± 0.02, and -0.03 ± 0.01 logMAR in treated and control eyes, respectively (P=0.3898), whereas AVTH improved by 1.0 ± 0.5 dB on treated eyes, with a trend towards significance for the comparison with the smaller AVTH improvement observed on control eyes: 0.2 ± 0.5 dB (P=0.0569). No significant difference was found between changes of BCEA 95% in treated (-1.8 ± 1.0), and control (-2.0 ± 1.8) eyes (P=0.5557). Corroborating to the microperimetry findings, 30-2 visual field mean deviations exhibited smaller worsening in treated (0.33 ± 0.70 dB) than in control (1.12 ± 0.58 dB) eyes after 48 weeks (P=0.0761). No significant changes were observed for any ERG parameters, or OCT during follow-up, and no side effects due to the injections were observed.
These data indicates that intravitreal injection of ABMSC is associated to a small improvement of macular thresholds on microperimetry, concomitant to a slight hindering of the 30-2 visual field sensitivity deterioration, one year after injection in RP. Further studies are needed to clarify possible mechanisms related to the potential use of ABMSC in RP.
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