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

NCT02445612 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2024-10-31

No results posted yet for this study

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.

Conditions

  • Stargardt's Macular Dystrophy

Interventions

BIOLOGICAL

MA09-hRPE

Cohort 1 50,000 cells Cohort 2 100,000 cells Cohort 2a Better Vision 100,000 cells Cohort 3 150,000 cells Cohort 4 200,000 cells

Sponsors & Collaborators

  • Astellas Institute for Regenerative Medicine

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Institute for Regenerative Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-11
Primary Completion
2019-06-21
Completion
2019-06-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02445612 on ClinicalTrials.gov