Study Details

A Follow up 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)

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.
NCT02941991

Astellas Study ID

The unique identification code given by the study sponsor.

7316-CL-0006

EudraCT ID

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

2012-002827-14

Condition

Eye Disorder with Progressive Visual Loss

Phase

N/A

Age

18 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment.

Observational

Trial Dates

Jan 2013 - Oct 2019

Masking

Not Available

Enrollment number

12

Follow-up to 5 Years of 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