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Gungor Sobaci, Koray Sevinc, Ercument Ovali, Emin Ozmert, Sengul Ozdek, Gursel Yilmaz, Hakan Durukan, Gokhan Gurelik, Figen Batioglu, Imren Akkoyun; SUBMACULAR ALLOGENEIC ECTO-MESENCHYMAL STEM CELL TRANSPLANTATION IN RETINITIS PIGMENTOSA: ONE-YEAR RESULTS. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):2276.
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To present the results of submacular olfactory ecto-mesenchymal stem cell (OEMSC) transplantation in patients with retinitis pigmentosa (RP) after 1-year follow-up.
This phase-1 clinical study approved by academic and government authorities and performed at Gulhane Military Medical Academy in Turkey included 10 adult retinitis pigmentosa patients (2 women, 8 men) with best-corrected visual acuity (BCVA) of HM to <20/200. In addition to full clinical examinations, ERG (Roland-Consult), macular OCT (Spectralis), microperimetry (MP1), and visual field examinations (Humprey) were used for evaluation of the treatment. Using transconjunctival pars plana approach without vitrectomy for the first, and with vitrectomy for the second injection performed 3 months after, OEMSCs, cultured from a single healthy adult donor, provided by GMP-certified laboratory (Acibadem-Labcell, Istanbul, Turkey), were injected into the submacular area through 41 G needle at a dose of 2x10(6) cells/0.2ml in eyes with worse BCVA. No topical and systemic anti-inflammatory agents were used.
None showed ocular or systemic inflammatory sign and tumorogenesis in 12- 15 months period. Epiretinal membrane in 5(40%) patients, choroidal neovascular membrane in 1 (10%), and retinal tear in 1 (10%) that occurred after the first injections were treated successfully using membranectomy in 5 and silicone oil in 2 patients in the second ones. OCT exams confirmed placement of SCs in the submacular area; increase in central foveal thickness (CFT) to normal values observed in 4 of 5 patients (80%) with macular atrophy at presentation. Treated eyes of 2 (20%) patients and both eyes of 2 patients (20%) maintained minimum 0.2 log unit BCVA improvement in this period. Six patients without BCVA improvement including the IOL implanted one did not show any decrease in BCVA, even 3 (30%) patients declared subjective improvement in peripheral vision in the untreated eye, which was confirmed by VFQ-25. Microperimetry and automated visual field testing were unrevealing due to low test-retest reliability on repeat exams at 1-year.
This novel technique seems to be promising for restoration of macular functions in advanced RP; however, manageable side effects due probably to vitreous seeding of SCs, and lessening of treatment effect from immune deviation might be considered for the long-term success.<br /> <!--[if !supportLineBreakNewLine]--><br /> <!--[endif]--><!--[endif]--><!--[if !supportLineBreakNewLine]--><br /> <!--[endif]-->
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