Umbilical cord derived mesenchymal stem cell implantation in retinitis pigmentosa: a 6-month follow-up results of a phase 3 trial

AIMTo investigate the efficacy and the safety of umbilical cord derived mesenchymal stem cell (UC-MSC) implantation in patients with retinitis pigmentosa (RP). METHODSThis prospective, single-center, phase 3 clinical study enrolled 124 eyes of 82 RP patients. The patients received 5 million UC-MSCs...

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Bibliographic Details
Published in:International journal of ophthalmology 2020-09, Vol.13 (9), p.1423-1429
Main Author: Kahraman, Neslihan Sinim
Format: Article
Language:English
Subjects:
cell mediated therapy
Clinical Research
retinitis pigmentosa
suprachoroidal
umbilical cord derived mesenchymal stem cells
visual function
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Summary:AIMTo investigate the efficacy and the safety of umbilical cord derived mesenchymal stem cell (UC-MSC) implantation in patients with retinitis pigmentosa (RP). METHODSThis prospective, single-center, phase 3 clinical study enrolled 124 eyes of 82 RP patients. The patients received 5 million UC-MSCs to the suprachoroidal area with a surgical procedure. Patients were evaluated on the 1st day, 1st, and 6th months postoperatively. Best corrected visual acuity (BCVA), anterior segment and fundus examinations, color photography, optical coherence tomography (OCT), and visual field (VF) tests were carried out at each visit. Fundus fluorescein angiography (FFA) and multifocal electroretinography (mfERG) recordings were performed at the end of the 6th month. Ocular and systemic adverse events of the surgical procedure were also noted. RESULTSAll of the 82 patients completed the 6-month follow-up period. None of them had any serious systemic or ocular complications. There were statistically significant improvements in BCVA and VF during the study (all P
ISSN:2222-3959
2227-4898
DOI:10.18240/ijo.2020.09.14