PURPOSE. A pilot Study of human neural retinal transplantation was undertak
en to investigate three major issues: whether a safe surgical procedure cou
ld be devised for transplantation of neural retinal tissue into the subreti
nal space, whether the transplant would be accepted in the subretinal space
, and whether an improvement in vision could be achieved.
METHODS. Eight patients with bare light perception (LP) vision due to retin
itis pigmentosa (RP) and one patient with bare LP vision due to advanced ne
ovascular age-related macular degeneration (AMD) received subretinal transp
lants of human fetal retinal microaggregate suspensions without postoperati
ve systemic immunosuppression. The patient with AMD also received a fetal r
etinal sheet transplant. The ages of the patients ranged from 31 to 94 year
s (median, 55 years). The pre- and postoperative evaluations included visua
l function testing, detailed fundus examinations, fundus photography, fluor
escein angiography. macular perimetry using a scanning laser ophthalmoscope
(SLO), and full field and focal electroretinograms (ERGs).
RESULTS. Three of the eight RP patients demonstrated possible improved ligh
t sensitivity during the initial months of follow-up. However, visual impro
vement disappeared between 3 and 13 months of follow-up. After transplantat
ion, no subject showed any changes in the ERG recordings or SLO macular per
imetry relative to their preoperative baseline. No patient experienced a re
tinal detachment, infection, or extensive bleeding. None of the patients de
veloped retinal vasculitis or intraocular inflammation. In one RP patient,
fluorescein angiography and fundus photography documented the formation and
maturation of new host retinal vessels in the area of the transplant.
CONCLUSIONS. Transplantation of fetal retinal photoreceptor suspensions int
o the subretinal space was achieved safely in nine subjects. Although a def
inite positive effect on visual function could not be demonstrated, the app
arent high tolerance for graft tissue is promising fur future efforts in th
e field of neural retinal transplantation.