Stem Cell Therapy for Age-Related Macular Degeneration

Phase 1 & 2

Waitlist Available

Research Sponsored by Astellas Institute for Regenerative Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant was treated with hESC-RPE cell therapy in an Astellas Institute for Regenerative Medicine (AIRM) sponsored clinical trial in macular degenerative disease

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at any negative effects that may occur years after treatment for a condition involving the retina, where cells from a human embryo were transplanted.

Who is the study for?

This study is for people who have previously received a specific stem cell treatment for macular degeneration in an AIRM-sponsored trial. Participants must be able to understand the nature of this follow-up study.

What is being tested?

The focus is on monitoring safety long-term, specifically looking for late onset adverse events that might be related to the stem cell therapy they received over 5 years ago.

What are the potential side effects?

Since this is a surveillance study, it's not testing new treatments but watching for delayed side effects from previous stem cell therapy which could include immune reactions or other unforeseen issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have received hESC-RPE cell therapy for macular degeneration in an AIRM trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All cause death

Incidents of ectopic tissue (RPE or non-RPE) formation

Incidents of hESC-RPE cell proliferation

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: hESC-RPE cellsExperimental Treatment1 Intervention

Participants previously enrolled into an Astellas Institute for Regenerative Medicine (AIRM) sponsored clinical trial and treated with Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial (hESC-RPE) cells

0 / 1Eligibility criteria met