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.