CompletedNot Applicable

Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Stargardt Macular Dystrophy Patients

United States13 participantsStarted 2012-07-11

Plain-language summary

The purpose of this study is to evaluate the long term safety and tolerability of MA09-hRPE cellular therapy in patients with advanced Stargardt's Macular Dystrophy (SMD) from one to five years following the surgical procedure to implant the MA09-hRPE 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 IDNCT02445612

SponsorAstellas Institute for Regenerative Medicine

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-06-21

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