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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)

NCT01469832 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-10-31

No results posted yet for this study

Summary

The purpose of this study is:

To evaluate the safety and tolerability of RPE cellular therapy in patients with SMD .

To evaluate potential efficacy endpoints to be used in future studies RPE cellular therapy.

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-13
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United Kingdom

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 NCT01469832 on ClinicalTrials.gov