A biosynthetic alternative to human donor tissue for inducing corneal regeneration: 24-Month follow-up of a phase 1 clinical study

Science Translational Medicine

Volumn 2, Issue 46, 2010, Pages

  Fagerholm, Per ^a   Lagali, Neil S ^a   Merrett, Kimberley ^b   Jackson, W Bruce ^b   Munger, Rejean ^b   Liu, Yuwen ^c   Polarek, James W ^d   Söderqvist, Monica ^e   Griffith, May ^a,b  

^a LINKÖPING UNIVERSITY   (Sweden)

^b UNIVERSITY OF OTTAWA EYE INSTITUTE   (Canada)

^c New Technologies and Research and Development   (United States)

^d FIBROGEN INC   (United States)

^e Synsam Opticians   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTICLE; BIOARTIFICIAL CORNEA; BIOARTIFICIAL ORGAN; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; CORNEA DISEASE; CORNEA EPITHELIUM; CORNEA SCAR; CORNEA STROMA; CORNEA THICKNESS; FOLLOW UP; HUMAN; INTRAOCULAR PRESSURE; KERATOCONUS; KERATOPLASTY; NERVE REGENERATION; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; TEAR FILM; TISSUE REGENERATION; TOUCH; VISUAL ACUITY; ADOLESCENT; ASTIGMATISM; CLINICAL TRIAL; CORNEA; DONOR; EXTRACELLULAR MATRIX; MIDDLE AGED; PATHOPHYSIOLOGY; REGENERATION;

ADOLESCENT; ADULT; AGED; ASTIGMATISM; CORNEA; EXTRACELLULAR MATRIX; FOLLOW-UP STUDIES; HUMANS; KERATOCONUS; MIDDLE AGED; REGENERATION; TISSUE DONORS; VISUAL ACUITY;

EID: 77956109772     PISSN: 19466234     EISSN: 19466242     Source Type: Journal    
DOI: 10.1126/scitranslmed.3001022     Document Type: Article

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41. Acknowledgments: We thank our many past and present collaborators, inparticular D. J. Carlsson, F. Li, C. P. Lohmann, K. Kobuch, M. Watsky, N. Shinozaki, Y. Kato, D. Priest, and C. R. McLaughlin. Funding: This study was supported by grants from the Swedish Research Council and County of Östergötland (to P.F.), a European Union Marie Curie International Fellowship (to N.S.L.), and the Canadian Stem Cell Network (to M.G.). Author contributions: P.F. performed surgeries, clinical follow-up, and clinical data collection and assisted in study design, data analysis and interpretation, and critical revision of the manuscript. N.S.L. assisted in study design, clinical data collection, data analysis, and interpretation; drafted the manuscript; and assisted in critical revision of the manuscript. K.M. developed the process of formulating the biosynthetic implants and assisted in manuscript revision. W.B.J. assisted in study design, clinical data collection, data interpretation, and critical revision of the manuscript. R.M. assisted in data analysis and interpretation, and critical manuscript revision. Y.L. fabricated the implants used in this study and assisted in manuscript revision. J.W.P. developed the recombinant human collagen used in this study and assisted in manuscript revision. M.S. assisted in postoperative clinical data collection, performed customcontact lens fitting in patients to achieve BCLVA, and assisted in manuscript revision. M.G. conceived the concept of endogenous corneal regeneration within a biosynthetic implant; oversaw development and production of the biosynthetic implants; and participated in study design, data analysis and interpretation, and manuscript preparation and critical revision. Competing interests: J.W.P. is vice president for Protein Therapeutics and Collagen Development at FibroGen Inc. and is compensated in part for his activities aimed at the development of recombinant human collagen for medical use. Patents relating to the production of recombinant human type III collagen used in the biosynthetic corneal implant described in this study are owned by FibroGen Inc. Recombinant human type III collagen materials are available under license from FibroGen Inc. None of the other authors had any conflict of interest from the time of recruitment and selection of patients to the time of publication. Although CooperVision GMP laboratories were used to fabricate the biosynthetic implants, the company has no commercial interest in the technology. A patent application related to the biomaterials formulation described in this study has been filed and assigned to the Ottawa Hospital Research Institute (OHRI) and is currently licensed to Eyegenix Inc., a wholly owned subsidiary of Cellular Bioengineering Inc., for use in corneal transplantation. An existing OHRI-LV Prasad Eye Institute, India, memorandum of understanding allows for fabrication and use of the biosynthetic implants for transplantation on a noncommercial basis. Accession numbers: EudraCT no. 2006-006585-42.