Sub-retinal Transplantation of hESC Derived RPE(MA09-hRPE)Cells in Patients With Stargardt's Macu… (NCT01345006) | Clinical Trial Compass
CompletedPhase 1/2
Sub-retinal Transplantation of hESC Derived RPE(MA09-hRPE)Cells in Patients With Stargardt's Macular Dystrophy
United States13 participantsStarted 2011-06-16
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 Stargardt's Macular Dystrophy (SMD).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Adult male or female over 18 years of age.
* Clinical diagnosis of advanced SMD.
* If known, the patient's genotype will be recorded in the medical history, if unknown, patient will allow for the submission of a sample for genotyping.Clinical findings consistent with SMD.
* 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.
* Peripheral visual field constriction documented on standard kinetic visual field testing.
* Electrophysiological findings consistent with SMD.
* 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:
* Normal serum chemistry (sequential multi-channel analyzer 20 \[SMA- 20\]) and hematology (complete blood count \[CBC\], prothrombin time \[PT\], and activated partial thromboplastin time \[aPTT\]) screening tests.
* Negative urine screen for drugs of abuse.
* Negative human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) serologies.
* No history of malignancy,with the exception of successfully treated basal cell or squamous cell …
What they're measuring
1
The safety and tolerance of transplantation of hESC-derived RPE cells MA09-hRPE
Timeframe: 12 months
2
Safety Assessments
Timeframe: 12 months
Trial details
NCT IDNCT01345006
SponsorAstellas Institute for Regenerative Medicine