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Rubens C Siqueira, Carina Costa Cotrim, Andre Messias, Monique Viana de Sousa, Luiza Toscano, Rodrigo Jorge; Intravitreal Autologous Bone Marrow Derived Stem Cells in Dry Age-related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3704.
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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 Dry Age-related Macular Degeneration (Dry AMD).
Prospective, single blind, phase I/II non-randomized clinical trial (ClinicalTrials.gov Identifier:NCT01518127), including 10 patients (10 eyes) with Dry 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 autologous bone marrow-derived cells containing CD34 +cells (0.1 ml), and were evaluated before injection (baseline), and at 1 , 3 and 6 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, 10 patients completed 1 and 3 months follow-up and only six completed 6 months. No significant ocular or systemic adverse effects were observed. There was a small but significant improvement on BCVA in logMAR , P = 0.0051, P = 0.0096 and P = 0.0018 (1.3 and 6 months respectively). 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 Dry 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.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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