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Stem Cell Therapy

Stem Cell Transplant for Age-Related Macular Degeneration

Phase 1 & 2
Recruiting
Led By Henry E Wiley, M.D.
Research Sponsored by National Eye Institute (NEI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be 55 years of age or older
Study eye must meet specific criteria including geographic atrophy and visual acuity requirements
Must not have
Participant unable or unwilling to give informed consent for current and future research
Participant has diagnosis of a malignancy expected to affect two-year survival
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, and 60 month
Awards & highlights

Summary

This trial is testing if it is safe to put cells in people's eyes as a possible future treatment for dry age-related macular degeneration. People who have had "wet" macular degeneration in either eye are not eligible.

Who is the study for?
This trial is for people over 55 with geographic atrophy from dry age-related macular degeneration, causing vision loss. Participants must have certain levels of visual acuity and be able to undergo surgery and follow-up visits. Pregnant individuals or those with 'wet' macular degeneration are excluded.
What is being tested?
The safety of transplanting lab-grown retinal cells into the eye is being tested as a treatment for dry age-related macular degeneration. Patients will receive these new cells through a surgical procedure in one eye, followed by extensive monitoring over several years.
What are the potential side effects?
Potential side effects may include discomfort from the various tests, risks associated with eye surgery such as infection or bleeding, possible reaction to anesthesia, and long-term unknown effects of having transplanted stem cell-derived tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 55 years old or older.
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My study eye has a specific type of retina damage and meets the vision sharpness requirements.
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I have been diagnosed with AMD in at least one eye.
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My study eye is clear and has an artificial lens or no lens.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not willing or able to agree to participate in this or future studies.
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My cancer diagnosis may impact my survival over the next two years.
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I have taken medication that could harm my eyes in the last year.
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My family has a history of eye diseases other than age-related macular degeneration.
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My study eye does not have conditions like neovascularization, glaucoma, or a history of eye surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 24, and 60 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 24, and 60 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Multifocal electroretinography responses
Retinal Structure (color and autofluorescence imaging)
Retinal Structure (optical coherence tomography)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants receiving interventionExperimental Treatment1 Intervention
Participants receiving intervention

Find a Location

Who is running the clinical trial?

National Eye Institute (NEI)Lead Sponsor
551 Previous Clinical Trials
1,406,893 Total Patients Enrolled
Henry E Wiley, M.D.Principal InvestigatorNational Eye Institute (NEI)
5 Previous Clinical Trials
171 Total Patients Enrolled
Shilpa M Kodati, M.D.Principal InvestigatorNational Eye Institute (NEI)
5 Previous Clinical Trials
698 Total Patients Enrolled

Media Library

Atuologous iPSC-derived RPE on PGLA (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04339764 — Phase 1 & 2
Age-Related Macular Degeneration Research Study Groups: Participants receiving intervention
Age-Related Macular Degeneration Clinical Trial 2023: Atuologous iPSC-derived RPE on PGLA Highlights & Side Effects. Trial Name: NCT04339764 — Phase 1 & 2
Atuologous iPSC-derived RPE on PGLA (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04339764 — Phase 1 & 2
~11 spots leftby May 2029
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