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Enrollment change, Trial completion date, Trial primary completion date: A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration (clinicaltrials.gov) - Dec 10, 2020 P1b, N=18, Active, not recruiting, Active, not recruiting --> Recruiting | Trial completion date: Nov 2022 --> Aug 2024 | Trial primary completion date: Nov 2022 --> Aug 2024 N=150 --> 18 | Trial completion date: Jan 2027 --> Nov 2022 | Trial primary completion date: Jan 2027 --> Nov 2022
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Trial completion, Trial completion date, Trial primary completion date, Metastases: Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Patients With AMD (clinicaltrials.gov) - Oct 30, 2019 P1/2, N=11, Completed, Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Jun 2019 | Trial primary completion date: Dec 2019 --> Jun 2019 Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Jul 2019 | Trial primary completion date: Dec 2019 --> Jul 2019
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Review, Journal: Transplantation of human embryonic stem cell-derived retinal pigment epithelial cells (MA09-hRPE) in macular degeneration. (Pubmed Central) - Sep 5, 2019 Given that the technology is still at its infancy for human use, a new clinical regulatory path could aid in cell line validation through small cohort, adaptive clinical trials to accelerate product development toward commercialization. These strategic insights will be invaluable to help both academia and industry, collaboratively shorten the steep learning curve, and reduce large development expenditures spent on unnecessary lengthy clinical trials.
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Enrollment change, Trial withdrawal, Trial primary completion date: Research With Retinal Cells Derived From Stem Cells for Myopic Macular Degeneration (clinicaltrials.gov) - Jul 19, 2016 P1/2, N=0, Withdrawn, N=60 --> 8 | Suspended --> Terminated; Changes to the study design and the cell line N=12 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Dec 2017 --> Jul 2016
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Enrollment open, Trial primary completion date: Research With Retinal Cells Derived From Stem Cells for Myopic Macular Degeneration (clinicaltrials.gov) - Feb 8, 2016 P1/2, N=12, Recruiting, Enrolling by invitation --> Active, not recruiting | Trial primary completion date: Dec 2029 --> Aug 2029 Not yet recruiting --> Recruiting | Trial primary completion date: Apr 2015 --> Dec 2017
- |||||||||| ASP7317 / Octapharma, Astellas
Enrollment closed, Trial primary completion date, Metastases: Safety and Tolerability of Sub-retinal Transplantation of hESC Derived RPE (MA09-hRPE) Cells in Patients With Advanced Dry Age Related Macular Degeneration (clinicaltrials.gov) - Apr 28, 2015 P1/2, N=16, Active, not recruiting, Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2014 --> Aug 2015 Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2014 --> Aug 2015
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