Six-month results of suprachoroidal adipose tissue-derived mesenchymal stem cell implantation in patients with optic atrophy: a phase 1/2 study
This prospective clinical case series aimed to investigate the safety and efficacy of suprachoroidal adipose tissue-derived mesenchymal stem cell (ADMSC) implantation in patients with optic nerve diseases.
This prospective, single-center, phase 1/2 study enrolled 4 eyes of 4 patients with optic atrophy of various reasons who underwent suprachoroidal implantation of ADMSCs. The best-corrected visual acuity (BCVA) in the study was HM at 1 m. The worse eye of the patient was operated. Patients were evaluated on the first day, first week, first month, third and sixth months postoperatively. BCVA, anterior segment and fundus examination, color photography, optical coherence tomography (OCT) and visual field examination were carried out at each visit. Fundus fluorescein angiography and multifocal electroretinography (mfERG) recordings were performed at the end of the first, third and sixth months and anytime if necessary during the follow-up.
All 4 patients completed the six-month follow-up. None of them had any systemic or ocular complications. All of the patients experienced visual acuity improvement, visual field improvement and improvement in the mfERG recordings. We found choroidal thickening in OCT of the 4 patients.
Even though the sample size is small, the improvements were still encouraging. Stem cell treatment with suprachoroidal implantation of ADMSCs seems to be safe and effective in the treatment for optic nerve diseases that currently have no curative treatment options.
KeywordsAdipose tissue-derived mesenchymal stem cell Optic nerve disease Suprachoroidal implantation
All authors have contributed significantly and are in agreement with the content of the manuscript.
This study is funded by The Scientific Research Support Division of the University (Grant Number TSA-2018-7816).
Compliance with ethical standards
Conflict of interest
All of the authors declare that they have no conflict of interest.
Ethics approval and consent to participate
All procedures performed in this study were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study was approved by the Institutional Review Board (Review number for approval: 2017/480, date: 13.10.2017). It was also approved by the Review Board of Stem Cell Applications within the Ministry of Health in accordance with the regulations in our country (Review number for approval: 56733164/203). All patients were instructed about the objectives and methodology of the study and gave written informed consent to participate.
Consent for publication
All patients gave written informed consent for publication of images.
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