Table 1.
Clinical trials using placenta-derived cells, fetal membranes, or derivatives in ophthalmic disorders.
Condition | Clinical trial ID | Phase | Materials used | Status | Sponsor | Results/status or remarks |
---|---|---|---|---|---|---|
Scleral thinning | NCT00801073 | II/III | AM graft | Enrolling | Federal University of São Paulo, Brazil | Primary Completion Date: February 2005, last verified December 2008 (de Farias et al., 2014) |
Bullous keratopathy | NCT01926535 | II | AM graft | Completed | Universidad de Valparaiso, Chile | None available, Study Completion Date: June 2012 |
NCT00659308 | ns | AM | Completed | Federal University of São Paulo, Brazil | Study Completion Date: June 2007, last verified January 2008 (Paris Fdos et al., 2013) | |
Pterygium or ocular surface cicatrizing diseases or keratitis | NCT02102776 | ns | AM | Not yet recruiting | Shiyou Zhou, Sun Yat-sen University, China | Estimated Study Completion Date: September 2016 |
NCT01319721 | ns | AM graft | Completed | Shiyou Zhou, Sun Yat-sen University, China | Results available online (https://clinicaltrials.gov), Study Completion Date: June 2014 | |
NCT00457223 | II/III | AM | Completed | Chulalongkorn University, Thailand | None available, study completed in 2007 | |
NCT00802620 | I | AM | Enrolling | Federal University of São Paulo, Brazil | None available, Primary Completion Date: June 2005, last verified December 2008 | |
NCT02015000 | ns | AM | Recruiting | National Taiwan University Hospital, Taiwan | Estimated Study Completion Date: November 2014, last verified December 2013 | |
NCT00383825 | ns | AM | Completed | Baskent University, Ankara, Turkey | None available, Estimated Study Completion Date: December 2004, last verified October 2006 | |
NCT00344201 | I | AM | Completed | Singapore National Eye Centre, Singapore | None available, Study Completion Date: January 2008 | |
NCT02116062 | ns | AM | Recruiting | University Hospital, Strasbourg, France | Estimated Study Completion Date: March 2016 | |
Corneal wounds or ulcers or epithelial defects | NCT00915759 | ns | ProKera® | Active | Walter Reed National Military Medical Center, Washington, DC, USA | Estimated Study Completion Date: December 2014, last verified July 2014 |
NCT02168790 | 0 | Amnioclip ring system | Completed | Klinikum Chemnitz gGmbH, Germany | None available, Study Completion Date: August 2013 | |
NCT00238862 | ns | AM | Completed | King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia | None available, study completed in 2007 | |
NCT02395952 | ns | ProKera®, Ambiodisk | Not yet recruiting | Milton S. Hershey Medical Center, PA, USA | Estimated Primary Completion Date: February 2018 | |
NCT02148016 | I/II | AM | Recruiting | Sun Yat-sen University, China | Estimated Study Completion Date: September 2014, last verified May 2014 | |
Limbal stem cell deficiency | NCT01377311 | I | AM | Terminated | National Taiwan University Hospital, Taiwan | Study terminated since technique not used in patients, last verified June 2011 |
NCT00736307 | I/II | AM | Completed | Royan Institute, Tehran, Iran | None available, Study Completion Date: October 2009, last verified April 2010 | |
NCT01562002 | I/II | AM | Completed | Instituto Universitario de Oftalmobiología Aplicada, Spain | None available, Study Completion Date: December 2014, last verified January 2015 | |
NCT01619189 | II | AM | Ongoing | Centre Hospitalier National d’Ophtalmologie des Quinze-Vingts, France | Primary Completion Date: December 2014, last verified February 2015 | |
NCT00491959 | I | AM | Terminated | National Taiwan University Hospital, Taiwan | Study terminated due to unstable cell sheet quality, thus this technique was not used on patients | |
Ocular surface disease and reconstruction | NCT00348114 | II | AM | Completed | Singapore National Eye Centre, Singapore | This study has suspended participant recruitment since 2006 |
NCT01341223 | ns | AM | Recruiting | National Taiwan University Hospital, Taiwan | Estimated Primary Completion Date: March 2016, last verified March 2012 | |
Dry eye syndrome | NCT02369861 | I | ACCS | Recruiting | Stemnion, Inc., Pittsburgh, PA, USA | Estimated Study Completion Date: December 2015 |
Glaucoma | NCT01551550 | II/III | AM graft | Recruiting | Tissue Tech™ Inc., Miami, FL, USA | Estimated Study Completion Date: August 2015 |
The search status as of June 2015 registered on the ClinicalTrials.gov site of U.S. National Institutes of Health (https://clinicaltrials.gov).
ns, not specified; AM, amniotic membrane; ACCS, amnion-derived Cellular Cytokine Solution (Stemnion, Inc.); ProKera® (Tissue Tech™ Inc.) is a device made by a piece of amniotic membrane tissue in between two rings made out of flexible material.