Phase 1 clinical study of an embryonic stem cell–derived retinal pigment epithelium patch in age-related macular degeneration

An engineered patch of retinal pigment epithelium generated from human embryonic stem cells is transplanted into the eyes of two patients. Age-related macular degeneration (AMD) remains a major cause of blindness, with dysfunction and loss of retinal pigment epithelium (RPE) central to disease progr...

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Published in	Nature biotechnology Vol. 36; no. 4; pp. 328 - 337
Main Authors	da Cruz, Lyndon, Fynes, Kate, Georgiadis, Odysseas, Kerby, Julie, Luo, Yvonne H, Ahmado, Ahmad, Vernon, Amanda, Daniels, Julie T, Nommiste, Britta, Hasan, Shazeen M, Gooljar, Sakina B, Carr, Amanda-Jayne F, Vugler, Anthony, Ramsden, Conor M, Bictash, Magda, Fenster, Mike, Steer, Juliette, Harbinson, Tricia, Wilbrey, Anna, Tufail, Adnan, Feng, Gang, Whitlock, Mark, Robson, Anthony G, Holder, Graham E, Sagoo, Mandeep S, Loudon, Peter T, Whiting, Paul, Coffey, Peter J
Format	Journal Article
Language	English
Published	New York Nature Publishing Group US 01.04.2018 Nature Publishing Group
Subjects	13 13/1 14 14/63 59 631/61/490 692/308/2171 Acuity Age Age related diseases Aged Agriculture Animals Basement Membrane - diagnostic imaging Basement Membrane - growth & development Bioinformatics Biomedical Engineering/Biotechnology Biomedicine Biotechnology Blindness Care and treatment Cell Differentiation - genetics Embryonic stem cells Epithelium Feasibility studies Female Health aspects Human Embryonic Stem Cells - transplantation Humans Immunosuppression Life Sciences Macular degeneration Macular Degeneration - diagnostic imaging Macular Degeneration - pathology Macular Degeneration - therapy Male Methods Mice Middle Aged Optical Coherence Tomography Patients Retina Retinal pigment epithelium Retinal Pigment Epithelium - diagnostic imaging Retinal Pigment Epithelium - growth & development Retinal Pigment Epithelium - transplantation Safety Stem cell transplantation Stem Cell Transplantation - adverse effects Stem cells Surgical instruments Swine Tomography, Optical Coherence Transplantation Tumorigenicity Visual acuity Visual Acuity - physiology
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Abstract	An engineered patch of retinal pigment epithelium generated from human embryonic stem cells is transplanted into the eyes of two patients. Age-related macular degeneration (AMD) remains a major cause of blindness, with dysfunction and loss of retinal pigment epithelium (RPE) central to disease progression. We engineered an RPE patch comprising a fully differentiated, human embryonic stem cell (hESC)–derived RPE monolayer on a coated, synthetic basement membrane. We delivered the patch, using a purpose-designed microsurgical tool, into the subretinal space of one eye in each of two patients with severe exudative AMD. Primary endpoints were incidence and severity of adverse events and proportion of subjects with improved best-corrected visual acuity of 15 letters or more. We report successful delivery and survival of the RPE patch by biomicroscopy and optical coherence tomography, and a visual acuity gain of 29 and 21 letters in the two patients, respectively, over 12 months. Only local immunosuppression was used long-term. We also present the preclinical surgical, cell safety and tumorigenicity studies leading to trial approval. This work supports the feasibility and safety of hESC-RPE patch transplantation as a regenerative strategy for AMD.
AbstractList	Age-related macular degeneration (AMD) remains a major cause of blindness, with dysfunction and loss of retinal pigment epithelium (RPE) central to disease progression. We engineered an RPE patch comprising a fully differentiated, human embryonic stem cell (hESC)-derived RPE monolayer on a coated, synthetic basement membrane. We delivered the patch, using a purpose-designed microsurgical tool, into the subretinal space of one eye in each of two patients with severe exudative AMD. Primary endpoints were incidence and severity of adverse events and proportion of subjects with improved best-corrected visual acuity of 15 letters or more. We report successful delivery and survival of the RPE patch by biomicroscopy and optical coherence tomography, and a visual acuity gain of 29 and 21 letters in the two patients, respectively, over 12 months. Only local immunosuppression was used long-term. We also present the preclinical surgical, cell safety and tumorigenicity studies leading to trial approval. This work supports the feasibility and safety of hESC-RPE patch transplantation as a regenerative strategy for AMD. An engineered patch of retinal pigment epithelium generated from human embryonic stem cells is transplanted into the eyes of two patients. Age-related macular degeneration (AMD) remains a major cause of blindness, with dysfunction and loss of retinal pigment epithelium (RPE) central to disease progression. We engineered an RPE patch comprising a fully differentiated, human embryonic stem cell (hESC)–derived RPE monolayer on a coated, synthetic basement membrane. We delivered the patch, using a purpose-designed microsurgical tool, into the subretinal space of one eye in each of two patients with severe exudative AMD. Primary endpoints were incidence and severity of adverse events and proportion of subjects with improved best-corrected visual acuity of 15 letters or more. We report successful delivery and survival of the RPE patch by biomicroscopy and optical coherence tomography, and a visual acuity gain of 29 and 21 letters in the two patients, respectively, over 12 months. Only local immunosuppression was used long-term. We also present the preclinical surgical, cell safety and tumorigenicity studies leading to trial approval. This work supports the feasibility and safety of hESC-RPE patch transplantation as a regenerative strategy for AMD. Age-related macular degeneration (AMD) remains a major cause of blindness, with dysfunction and loss of retinal pigment epithelium (RPE) central to disease progression. We engineered an RPE patch comprising a fully differentiated, human embryonic stem cell (hESC)-derived RPE monolayer on a coated, synthetic basement membrane. We delivered the patch, using a purpose-designed microsurgical tool, into the subretinal space of one eye in each of two patients with severe exudative AMD. Primary endpoints were incidence and severity of adverse events and proportion of subjects with improved best-corrected visual acuity of 15 letters or more. We report successful delivery and survival of the RPE patch by biomicroscopy and optical coherence tomography, and a visual acuity gain of 29 and 21 letters in the two patients, respectively, over 12 months. Only local immunosuppression was used long-term. We also present the preclinical surgical, cell safety and tumorigenicity studies leading to trial approval. This work supports the feasibility and safety of hESC-RPE patch transplantation as a regenerative strategy for AMD.Age-related macular degeneration (AMD) remains a major cause of blindness, with dysfunction and loss of retinal pigment epithelium (RPE) central to disease progression. We engineered an RPE patch comprising a fully differentiated, human embryonic stem cell (hESC)-derived RPE monolayer on a coated, synthetic basement membrane. We delivered the patch, using a purpose-designed microsurgical tool, into the subretinal space of one eye in each of two patients with severe exudative AMD. Primary endpoints were incidence and severity of adverse events and proportion of subjects with improved best-corrected visual acuity of 15 letters or more. We report successful delivery and survival of the RPE patch by biomicroscopy and optical coherence tomography, and a visual acuity gain of 29 and 21 letters in the two patients, respectively, over 12 months. Only local immunosuppression was used long-term. We also present the preclinical surgical, cell safety and tumorigenicity studies leading to trial approval. This work supports the feasibility and safety of hESC-RPE patch transplantation as a regenerative strategy for AMD.
Audience	Academic
Author	Fynes, Kate Hasan, Shazeen M Vugler, Anthony da Cruz, Lyndon Tufail, Adnan Georgiadis, Odysseas Kerby, Julie Feng, Gang Fenster, Mike Daniels, Julie T Luo, Yvonne H Nommiste, Britta Sagoo, Mandeep S Whiting, Paul Gooljar, Sakina B Whitlock, Mark Wilbrey, Anna Harbinson, Tricia Holder, Graham E Loudon, Peter T Coffey, Peter J Carr, Amanda-Jayne F Ramsden, Conor M Steer, Juliette Vernon, Amanda Robson, Anthony G Ahmado, Ahmad Bictash, Magda
Author_xml	– sequence: 1 givenname: Lyndon surname: da Cruz fullname: da Cruz, Lyndon email: Lyndon.dacruz@Moorfields.nhs.uk organization: The London Project to Cure Blindness, ORBIT, Institute of Ophthalmology, University College London (UCL), NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust, Wellcome/EPSRC Centre for Interventional & Surgical Sciences (WEISS), Charles Bell House – sequence: 2 givenname: Kate surname: Fynes fullname: Fynes, Kate organization: The London Project to Cure Blindness, ORBIT, Institute of Ophthalmology, University College London (UCL) – sequence: 3 givenname: Odysseas surname: Georgiadis fullname: Georgiadis, Odysseas organization: The London Project to Cure Blindness, ORBIT, Institute of Ophthalmology, University College London (UCL), NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust – sequence: 4 givenname: Julie surname: Kerby fullname: Kerby, Julie organization: Pfizer, Granta Park, Cell and Gene Therapy Catapult – sequence: 5 givenname: Yvonne H surname: Luo fullname: Luo, Yvonne H organization: The London Project to Cure Blindness, ORBIT, Institute of Ophthalmology, University College London (UCL), NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust – sequence: 6 givenname: Ahmad surname: Ahmado fullname: Ahmado, Ahmad organization: The London Project to Cure Blindness, ORBIT, Institute of Ophthalmology, University College London (UCL) – sequence: 7 givenname: Amanda surname: Vernon fullname: Vernon, Amanda organization: Cells for Sight, Transplantation & Research Program, UCL Institute of Ophthalmology – sequence: 8 givenname: Julie T surname: Daniels fullname: Daniels, Julie T organization: Cells for Sight, Transplantation & Research Program, UCL Institute of Ophthalmology – sequence: 9 givenname: Britta surname: Nommiste fullname: Nommiste, Britta organization: The London Project to Cure Blindness, ORBIT, Institute of Ophthalmology, University College London (UCL) – sequence: 10 givenname: Shazeen M surname: Hasan fullname: Hasan, Shazeen M organization: The London Project to Cure Blindness, ORBIT, Institute of Ophthalmology, University College London (UCL) – sequence: 11 givenname: Sakina B surname: Gooljar fullname: Gooljar, Sakina B organization: The London Project to Cure Blindness, ORBIT, Institute of Ophthalmology, University College London (UCL) – sequence: 12 givenname: Amanda-Jayne F orcidid: 0000-0002-5469-0030 surname: Carr fullname: Carr, Amanda-Jayne F organization: The London Project to Cure Blindness, ORBIT, Institute of Ophthalmology, University College London (UCL) – sequence: 13 givenname: Anthony surname: Vugler fullname: Vugler, Anthony organization: The London Project to Cure Blindness, ORBIT, Institute of Ophthalmology, University College London (UCL) – sequence: 14 givenname: Conor M surname: Ramsden fullname: Ramsden, Conor M organization: The London Project to Cure Blindness, ORBIT, Institute of Ophthalmology, University College London (UCL), Moorfields Eye Hospital NHS Foundation Trust – sequence: 15 givenname: Magda surname: Bictash fullname: Bictash, Magda organization: Pfizer, Granta Park – sequence: 16 givenname: Mike surname: Fenster fullname: Fenster, Mike organization: Pfizer, Granta Park – sequence: 17 givenname: Juliette surname: Steer fullname: Steer, Juliette organization: Pfizer, Granta Park – sequence: 18 givenname: Tricia surname: Harbinson fullname: Harbinson, Tricia organization: Pfizer, Granta Park – sequence: 19 givenname: Anna surname: Wilbrey fullname: Wilbrey, Anna organization: Pfizer, Granta Park – sequence: 20 givenname: Adnan surname: Tufail fullname: Tufail, Adnan organization: NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust – sequence: 21 givenname: Gang surname: Feng fullname: Feng, Gang organization: Pfizer, Granta Park – sequence: 22 givenname: Mark surname: Whitlock fullname: Whitlock, Mark organization: Pfizer, Granta Park – sequence: 23 givenname: Anthony G surname: Robson fullname: Robson, Anthony G organization: NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust – sequence: 24 givenname: Graham E surname: Holder fullname: Holder, Graham E organization: NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust – sequence: 25 givenname: Mandeep S surname: Sagoo fullname: Sagoo, Mandeep S organization: NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust – sequence: 26 givenname: Peter T surname: Loudon fullname: Loudon, Peter T organization: Pfizer, Granta Park – sequence: 27 givenname: Paul surname: Whiting fullname: Whiting, Paul organization: Pfizer, Granta Park, UCL Institute of Neurology, Queen Square – sequence: 28 givenname: Peter J surname: Coffey fullname: Coffey, Peter J organization: The London Project to Cure Blindness, ORBIT, Institute of Ophthalmology, University College London (UCL), NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, Center for Stem Cell Biology and Engineering, NRI, UC
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/29553577$$D View this record in MEDLINE/PubMed
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Snippet	An engineered patch of retinal pigment epithelium generated from human embryonic stem cells is transplanted into the eyes of two patients. Age-related macular... Age-related macular degeneration (AMD) remains a major cause of blindness, with dysfunction and loss of retinal pigment epithelium (RPE) central to disease...
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SubjectTerms	13 13/1 14 14/63 59 631/61/490 692/308/2171 Acuity Age Age related diseases Aged Agriculture Animals Basement Membrane - diagnostic imaging Basement Membrane - growth & development Bioinformatics Biomedical Engineering/Biotechnology Biomedicine Biotechnology Blindness Care and treatment Cell Differentiation - genetics Embryonic stem cells Epithelium Feasibility studies Female Health aspects Human Embryonic Stem Cells - transplantation Humans Immunosuppression Life Sciences Macular degeneration Macular Degeneration - diagnostic imaging Macular Degeneration - pathology Macular Degeneration - therapy Male Methods Mice Middle Aged Optical Coherence Tomography Patients Retina Retinal pigment epithelium Retinal Pigment Epithelium - diagnostic imaging Retinal Pigment Epithelium - growth & development Retinal Pigment Epithelium - transplantation Safety Stem cell transplantation Stem Cell Transplantation - adverse effects Stem cells Surgical instruments Swine Tomography, Optical Coherence Transplantation Tumorigenicity Visual acuity Visual Acuity - physiology
Title	Phase 1 clinical study of an embryonic stem cell–derived retinal pigment epithelium patch in age-related macular degeneration
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