Safety and Tolerability of Sub-retinal Transplantation of hESC Derived RPE (MA09-hRPE) Cells in P… (NCT01344993) | Clinical Trial Compass
CompletedPhase 1/2
Safety and Tolerability of Sub-retinal Transplantation of hESC Derived RPE (MA09-hRPE) Cells in Patients With Advanced Dry Age Related Macular Degeneration
United States13 participantsStarted 2011-06-09
Plain-language summary
This is a safety and tolerability trial to evaluate the effect of subretinal injection of human embryonic stem cell derived retinal pigment epithelium cells in patients with dry Age Related Macular Degeneration (AMD) and to perform exploratory evaluation of potential efficacy endpoints to be used in future studies retinal pigment epithelium (RPE) cellular therapy.
Who can participate
Age range55 Years
SexALL
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Inclusion Criteria:
* Adult male or female over 55 years of age.
* Patient should be in sufficiently good health to reasonably expect survival for at least four years after treatment
* Clinical findings consistent with advanced dry AMD with evidence of one or more areas of \>250microns of geographic atrophy (as defined in the Age-Related eye Disease Study \[AREDS\] study) involving the central fovea.
* GA defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, and FA.
* No evidence of current or prior choroidal neovascularization in the treated eye
* The visual acuity of the eye to receive the transplant will be no better than 20/400. The visual acuity of the eye in the better vision cohort to receive the transplant will be no better than 20/100.
* The visual acuity of the eye that is not to receive the transplant will be no better than 20/400 for the worse vision patients and no worse than 20/100 for the better vision patients.
* Electrophysiological findings consistent with advanced dry AMD.
* Medically suitable to undergo vitrectomy and subretinal injection.
* Medically suitable for general anesthesia or waking sedation, if needed.
* Medically suitable for transplantation of an embryonic stem cell line:
Any laboratory value which falls slightly outside of the normal range will be reviewed by the Medical Monitor and Investigators to determine its clinical significance. If it is determined not to be clinically significant, the patient may be enrolled into …
What they're measuring
1
Safety of hESC derived RPE cells
Timeframe: 12 Months
Trial details
NCT IDNCT01344993
SponsorAstellas Institute for Regenerative Medicine