Abstract
Purpose:To examine the safety of a single intravitreal injection of autologous bone Marrow Mesenchymal stem cells (MSCs) in patients with advanced retinitis pigmentosa (RP).Methods:A prospective, phase I, nonrandomized, open-label study was conducted on 3 eyes of 3 volunteers with advanced RP. Visual acuity, slit-lamp examination, fundus examination, optical coherence tomography, fundus auto-fluorescence, fluorescein angiography and multifocal electroretinography were performed before and after an intravitreal injection of approximately one-million MSCs. The patients were followed for one year. Further evaluation of MSCs was performed by injection of these cells into the mouse vitreous cavity.Results:No, adverse events were observed in eyes of 2 out of 3 patients after transplantation of MSCs. These patients reported improvements in perception of the light after two weeks, which lasted for 3 months. However, severe fibrous tissue proliferation was observed in the vitreous cavity and retrolental space of the third patient's eye, which led to tractional retinal detachment (TRD), iris neovascularization and formation of mature cataract. Injection of this patient's MSCs into the vitreous cavity of mice also resulted in fibrosis; however, intravitreal injections of the two other patients' cells into the mouse vitreous did not generate any fibrous tissue.Conclusion:Intravitreal injection of autologous bone marrow MSCs into patients' eyes with advanced RP does not meet safety standards. Major side effects of this therapy can include fibrosis and TRD. We propose thorough evaluation of MSCs prior to transplantation by intravitreal injection in the laboratory animals.\\
Highlights
Recent preclinical studies, and clinical trials suggest bone marrow‐derived cells for the treatment of retinal degenerative diseases.[1,2,3,4,5,6,7,8,9,10,11] This improvement in retinal function can be attained through different mechanisms such as the paracrine effect and retinal pigment epithelium (RPE) repair.[12]
We investigated the safety and feasibility of intravitreally transplanted autologous bone marrow mesenchymal stem cells (MSCs) in patients with advanced retinitis pigmentosa (RP) over a one‐year period
Intravitreal injection of MSCs of all a a b c b d e three patients was performed in the mice eyes (n = 17) and the injected eyes were monitored repeatedly with the retina morphometry
Summary
Clinical trials suggest bone marrow‐derived cells for the treatment of retinal degenerative diseases.[1,2,3,4,5,6,7,8,9,10,11] This improvement in retinal function can be attained through different mechanisms such as the paracrine effect and RPE repair.[12] The safety and efficacy of intravitreal injection of bone marrow mesenchymal stem cells (MSCs) in restoring retinal function in patients with retinitis pigmentosa (RP), has not been explored. We investigated the safety and feasibility of intravitreally transplanted autologous bone marrow MSCs in patients with advanced RP over a one‐year period. We report the early onset of severe fibrosis after cell transplantation in one patient's eye. Temporary improvement in visual function was observed
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