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Carina Costa Cotrim, Rodrigo Jorge, Andre Messias, Monique Viana de Sousa, Luiza Toscano, Rubens C Siqueira; Intravitreal Autologous Bone-Marrow Stem Cells in nonexudative macular degeneration (dry AMD) patients: Results after 3 Months Follow-up. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3783. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the effects of a single intravitreal injection of autologous bone-marrow stem cells (ABMSC) in nonexudative macular degeneration (dry AMD) patients.
Prospective, single blind, phase I/II non-randomized clinical trial, including 10 patients (10 eyes) with atrophic AMD showing best-corrected visual acuity (BCVA) of 20/160, or worse, and no history of cancer or other ocular condition. Patients underwent intravitreal injection of approximately 106 CD 34+ autologous bone marrow-derived cells (0.1 ml), and were evaluated before injection (baseline), and at 1 and 3 months during follow-up. A comprehensive ophthalmological evaluation was performed, including BCVA measurement, multifocal Electroretinography (mfERG - Diagnosys LLC), fluorescein angiography, autofluorescence, optical coherence tomography (s-OCT Heidelberg Engineering) and microperimetry (MAIA - Centervue) to access central (20 degrees) retinal sensitivity average threshold (AT), and the bivariate contour ellipse area (BCEA) as a measure of the fixation stability.
So far, 8 and 6 patients completed 1, and 3 months follow-up, respectively. No significant ocular or systemic adverse effects were observed. There was a small but significant improvement on BCVA of 0.16 ± 0.05 (P = 0.0054) logMAR at 1, and 0.17 ± 0.06 (P = 0.0151) logMAR at 3 months (baseline: 20/324; 1 month: 20/227; and 3 months: 20/211). No significant changes were observed for microperimetry parameters: AT or BCEA, or macular structure on s-OCT.
These data indicate that intravitreal injection of autologous bone marrow-derived cells seems to be safe in eyes with atrophic AMD, and in this small cohort was associated with slight improvement in visual acuity after three months. A larger number of cases and a longer follow-up are needed to confirm these findings.
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