A Safety Surveillance Study in Subjects With Macular Degenerative Disease Treated With Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Conditions

• Macular Degenerative Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells — BIOLOGICAL
  Participants who have received sub-retinal transplant of hESC-RPE cells in an AIRM sponsored clinical trial

Study Details

The purpose of this study is to is to evaluate the occurrence of late onset (i.e., greater than 5 years after treatment) adverse events of special interest (AESI) in participants who have received sub-retinal transplant of human embryonic stem cell derived - retinal pigment epithelial (hESC-RPE) cells in an AIRM-sponsored clinical trial. The events of special interest are adverse events (AEs) that are presumed to have a potential causal relationship to the hESC-RPE cells.

Key Dates

Start date

Jan 8, 2018

Status verified

Jun 2026

Primary completion

Mar 31, 2029

Completion

Mar 31, 2029

Study Design

Enrollment

36 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: hESC-RPE cells
  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

Primary Outcome Measure

Number of adverse events (AEs) that are ophthalmologic, neurologic, infectious or hematologic [ Time Frame: Up to 15 Years ]

Locations (1)

Find similar trials in Kansas City, MO

Related Studies

• Effect of Lutein, Zeaxanthin, and Meso-Zeaxanthin Supplementation on Skin Carotenoid Concentration: A Six-Month, Placebo-Controlled Crossover Study
  Recruiting · Insight Eyecare Specialties, Inc. dba Vision Source Eyecare, · Kansas City, Missouri