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Gungor Sobaci, Emin Ozmert, Ercumant Ovali, Sengul Ozdek, Gursel Yilmaz, Gokhan Gurelik, Hakan Durukan, Figen Batioglu, Imren Akkoyun, Mehmet Koray Sevinc; SUBMACULAR ALLOGENEIC ECTO-MESENCHYMAL STEM CELL TRANSPLANTATION IN RETINITIS PIGMENTOSA. Invest. Ophthalmol. Vis. Sci. 2014;55(13):5012.
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To evaluate the safety and the efficacy of submacular olfactory ecto-mesenchymal stem cell (OEMSC) transplantation in patients with retinitis pigmentosa (RP).
This phase 1 clinical study approved by academic and government authorities and performed at Gulhane Military Medical Academy in Turkey includes 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 10-2; 30-2) were used for evaluation of the treatment. Using transconjuctival pars plana approach without vitrectomy in the eye with worse BCVA, OEMSCs, cultured from a single healthy adult donor, provided by GMP-certified laboratory (Acibadem-Labcell) were injected into the submacular area through 41 G needle at a dose of 2x10(6) cells/0.2ml. No topical and systemic anti-inflammatory agents were used. They were followed regularly.
None showed ocular or systemic inflammatory sign and tumor development in the early period. Intravitreal membrane developed in 1 (10%) patient which was treated with vitrectomy successfully within the first month; silent epimacular membrane in 1(10%), and submacular membrane in 1(10%) were observed. OCT exams confirmed the sensory retinal detachment and placement of SCs in the submacular area within 6 hours and settlement of the cells subfoveally within a month. Five (50%) patients showed minimum 0.1log unit BCVA improvement together with patients’ satisfaction; even 1 patient (10%) with CF at 4 meter gained 20/100 vision after the first month. Central foveal thickness (CFT) increased to normal in 4 of 5 patients (80%) with low CFT. Retinal sensitivity increased 4 dB or more at locations within 10-degree in 6 (60%) patients, and central fixation improved in 5 of 7 (71%) with fixation disability, which was confirmed by patient questionnaire.
This novel technique with injection of allogeneic adult OEMSC into the submacular area without immunosuppression in RP patients seems to be promising for replacement/restoration of macular functions; manageable side effects, however, might be considered.
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