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Felipe Placeres Borges, Rubens C Siqueira, Murilo Wendeborn Rodrigues, Amanda Jardim Dos Santos, Andre Messias, Rodrigo Jorge; Intravitreal Autologous Bone Marrow Derived Stem Cells in Ischemic Maculopathy Results after 12 Months Follow-up. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3741.
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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 in retinal vascular diseases with ischemic maculophaty
Prospective, single blind, phase I/II non-randomized clinical trial (ClinicalTrials.gov Identifier: NCT01518842), including 15 patients (15 eyes) with ischemic maculopathy due to diabetic retinopathy (DR), central retinal vein occlusion (CRVO) or central retinal artery occlusion (CRAO) showing best-corrected visual acuity (BCVA) of 0.4 logMAR or worse, absence of active neovascularization, media opacity, prior vitrectomy and ocular pathologies. Patients underwent intravitreal injection of approximately 106(0,1mL) autologous bone marrow-derived mononuclear cells (containing CD 34+ cells) and were evaluated before injection (baseline), and monthly during follow-up. A comprehensive ophthalmological evaluation was performed, including BCVA measurement,full field electroretinography, multifocalelectroretinography,microperimetry, fluorescein angiography, SD-OCT and adaptive optics imaging.
So far, 16 eyes were treated, 9 completed the 12-month follow-up, 2 were excluded for diabetic medical complications. From the treated eyes, 2 had macular ischemia due to arterial occlusion, 5 due to venous occlusion and 9 due to DR. Parameters were analyzed for months 1,3, 6 and 12. No significant changes were observed for all parameters. No significant ocular or systemic adverse effects were observed. There was a small but no significant improvement on BCVA in logMAR , P = 0.3655, P = 0.3655 and P = 0.3743 (1, 3 and 12 months respectively).
Intravitreal injection of autologous bone-marrow stem cells (ABMSC) seem to be safe in eyes with ischemic maculopathy, and in this small cohort was associated with no significant changes in twelve 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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