CompletedNot Applicable

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)

United Kingdom12 participantsStarted 2013-01-16

Plain-language summary

The purpose of this study is to evaluate the long term safety and tolerability of hESC-RPE cellular therapy in patients with advanced SMD from 1 to 5 years following the surgical procedure to implant the hESC-RPE cells.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Must have been treated with hESC-RPE cell transplant in the core protocol. * Able to understand and willing to sign the informed consent to participate in the follow-up study. Exclusion Criteria: * There are no exclusion criteria

What they're measuring

Safety assessed by Adverse Events (AEs) of special interest in regards to the investigational product

Timeframe: 4 years

Trial details

NCT IDNCT02941991

SponsorAstellas Institute for Regenerative Medicine

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-10-02

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