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Article History

Received: 6 October 2020

Accepted: 8 March 2021

First Online: 19 March 2021

Declarations

:

: Cornea rims from human deceased donors were obtained from the Lions Eye Bank of the University Eye Clinic of Heidelberg, Germany, in cooperation with the German Society for Tissue Transplantation (DGFG), as leftover tissue from cornea transplantations in accordance with the German Act on Organ and Tissue Donation, Removal and Transplantation (“Transplantationsgesetz”) and its amending tissue regulation (TPG-GewV).The animal experiments were performed by specialist contract research organizations in France (Charles River Laboratories France Safety Assessment SAS, Saint-Germain-Nuelles; local biodistribution and toxicity study), meeting the animal protection requirements defined in the European and French animal welfare legislations, and the USA (Toxikon Corporation, Bedford, MA; systemic biodistribution and toxicity/tumorigenicity studies), meeting all relevant animal welfare regulation and strictly adhering to the animal welfare standards defined by the U.S. Department of Agriculture (USDA; 9 CFR Ch. 1), National Research Council (“Guide for the Care and Use of Laboratory Animals”), Office for Laboratory Animal Welfare (OLAW; “Public Health Service Policy on Human Care and Use of Laboratory Animals”), ISO 10993-2, and Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC).The clinical trial was approved by the Ethics Committee at the Medical Faculty of the University of Heidelberg (Heidelberg, Germany) and the Human Studies Committee at the Massachusetts Eye and Ear Infirmary (Boston, MA, USA) as the relevant independent ethics committees/institutional review boards) and by the Paul Ehrlich Institute (Germany) and the U.S. Food and Drug Administration as the competent national regulatory authorities. Before enrolment, all patients must give their written informed consent to participate in the trial.

: Not applicable.

: MHF and NYF are inventors or co-inventors of US and international patents assigned to Brigham and Women’s Hospital and/or Boston Children’s Hospital (Boston, MA, USA), licensed to TICEBA GmbH (Heidelberg, Germany) and RHEACELL GmbH & Co. KG (Heidelberg, Germany). MHF serves as scientific advisor to TICEBA and RHEACELL. AN, JE, ENR, SB, NS, and SSa are employees of TICEBA. HMS, KD, and AKD are and UD was employee of RHEACELL. CG is the CEO, and MAK is the CSO of TICEBA and RHEACELL. The remaining authors declare no competing interests.