Page 126 - ESHRE2019
P. 126

 Clinical trials with hESC-derivatives Macular degeneration
Lancet 2012
• No adverse secondary effects (rejection, adverse proliferation...)(SAEs)
• Vision improvement 17/18
PCC Stem Cells - ESHRE Vienna 2019
  Clinical trials with hESC-derivatives Macular degeneration
Mehat et al, Ophtalmology, 2018
- Focal areas of subretinal hyperpigmentation developed in all participants (12 patients)
- No evidence of uncontrolled proliferation or inflammatory responses.
- Borderline improvements in best-corrected VA in 4 participants either were unsustained or were
matched by a similar improvement in the untreated contralateral eye.
- Microperimetry demonstrated no evidence of benefit at 12 months in the 12 participants. In one
instance at the highest dose, localized retinal thinning and reduced sensitivity in the area of
hyperpigmentation suggested the potential for harm.
- Participant-reported quality of life using the 25-item National Eye Institute Visual Function
PCC Stem Cells - ESHRE Vienna 2019
    Given the slow rate of progressive degeneration at this advanced stage of disease, any protection against further deterioration may be evident only after a more extended period of observation.
 124
121
 















































































   124   125   126   127   128