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Re: lasers post# 80684

Friday, 01/30/2015 1:42:34 PM

Friday, January 30, 2015 1:42:34 PM

Post# of 92948
Lancet Publication makes it clear distinguishing between phase1 and phase2. Phase1 to assess the primary endpoints safety and phase2 to assess tolerability

https://www.ocata.com/research-development/scientific-papers

Methods In the USA, two prospective phase 1/2 studies were done to assess the primary endpoints safety and tolerability of subretinal transplantation of hESC-derived retinal pigment epithelium in nine patients with Stargardt’s macular dystrophy (age >18 years) and nine with atrophic age-related macular degeneration (age >55 years). Three dose cohorts (50 000, 100 000, and 150 000 cells) were treated for each eye disorder. Transplanted patients were followed up for a median of 22 months by use of serial systemic, ophthalmic, and imaging examinations. The studies are registered with ClinicalTrials.gov, numbers NCT01345006 (Stargardt’s macular dystrophy) and NCT01344993(age-related macular degeneration).



There are more references to the Phase1 and Phase2 in the Lancet Publication.

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