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. 2022 Jan 8;23(2):682. doi: 10.3390/ijms23020682

Table 1.

Resume of published clinical trials.

Authors N= Transplant Type Scaffold Delivery Technique Adverse Events BCVA Improvement (ETDRS)
DRY AMD Schwartz et al. 9 hESC-derived suspension n/a Subretinal injection (38G) after vitrectomy 1 vitreous inflammation
1 mild ERM
1 cataract
15 letters in 4 eyes
11–14 letters in 3 eyes
<10 letters in 3 eyes
Riemann et al. (poster) 16
(4 different cohorts)
hESC-derived RPE cells suspension n/a -PPV
retinotomy
-Orbit subretinal delivery system (SDS)
PPV group 2 severe ERM

SDS group
eyelid edema and subconjunctival hemorrhage
10–22 letters
(cohort 4 n = 4)
Kashani et al. 5 hESC-derived RPE monolayers
3.5 mm × 6.25 mm
Parylene C PPV and retinotomy 17 letters in 1 patient, none in the other 3
WET AMD Tezel et al. 12 adult human allogeneic RPE cells n/a PPV and subfoveal membranectomy with transplantation 6 graft fibrosis,
3 retinal detachments with PVR,
2 ERM,
1 graft migration
No change
Binder et al. 53 (39 transplanted, 14 controls) Autologous RPE cellular suspension n/a PPV and subretinal injection None Better reading acuity and higher mfERG-response density than control subjects
Mandai et al. 1 autologous (iPSC) from skin fibroblasts
1.3 mm × 3 mm
no PPV, membranectomy and patch implant No change
Da Cruz et al. 2 with subretinal hemorrhage hESC 6 mm × 3 mm PET 1 retinal detachment 29 and 21 letters
Sugita et al. 5 HLA homozygote iPS cellular suspension Subretinal injection (38G) after vitrectomy 2 mild rejections
1 ERM
No change
STGD1 Schwartz et al. 9 hESC-derived RPE cells suspension Subretinal injection after vitrectomy 3 cataracts
1 vitreous inflammation
At 6 months:
At least 15 letters in 3 eyes, stable in 4 eyes and 1 eye lost 11 letters.
At 12 months:
At least 15 letters in 3 patients, stable in 3 patients, and 1 had a decrease of more than 10 letters.
Mehat et al. 12 hESC line MA09-derived RPE cellular suspension Subretinal injection (38G) after vitrectomy 5 immunosuppression related events. 1nonpigmented and noncontractile epiretinal membrane.
2 visual floaters.
No change
Li et al. 7 hESC-derived RPE cells suspension -PPV
-injection of saline solution (41G) to detach the temporal retina.
-cellular into the macular sub-retinal space.
2 transient increases in intraocular pressure (26–32 mmHg). At 1–4 months:
7 eyes had transiently increased or stable visual function
At the last follow-up visit:
visual function loss in 2 eyes (1 of them stable when compared to the fellow eye).
Sung et al. 3 hESC-derived RPE cells suspension Subretinal injection after vitrectomy 1 eye showed improvement,
1 eye showed stability

PPV: pars plana vitrectomy, ERM: epiretinal membrane.