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Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (hESC-RPE) Cells in Patients with Stargardt's Macular Dystrophy (SMD)

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01469832

Astellas Study ID

The unique identification code given by the study sponsor.

7316-CL-0003

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2011-000054-34

Follow Trial

Condition

Eye Disorder with Progressive Visual Loss

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

18 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Dec 2011 - Sep 2015

Masking

None (Open Label)

Enrollment number

12

A Phase I/II, Open-Label, Multi-Center, Prospective Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial (hESC-RPE) Cells in Patients with Stargardt's Macular Dystrophy (SMD)

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Newcastle on Tyne NHS Foundation Trust

Newcastle upon Tyne, United Kingdom, NE7 7DN

Moorefields Eye Hospital NHS Foundation Trust

London, United Kingdom, EC1V2PD

Lothian Health Board Headquarters at Waverley Gate

Edinburgh, United Kingdom, EH1 3EG

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