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Stem Cell Therapy
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All cause death
Incidents of ectopic tissue (RPE or non-RPE) formation
Incidents of hESC-RPE cell proliferation
+5 moreTrial 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
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Who is running the clinical trial?
Astellas Institute for Regenerative MedicineLead Sponsor
8 Previous Clinical Trials
116 Total Patients Enrolled
Medical MonitorStudy DirectorAstellas Institute for Regenerative Medicine
1,649 Previous Clinical Trials
979,689 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received hESC-RPE cell therapy for macular degeneration in an AIRM trial.
Research Study Groups:
This trial has the following groups:- Group 1: hESC-RPE cells
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor currently accept volunteers?
"According to the data found on clinicaltrials.gov, this medical experiment is no longer recruiting patients; it was first posted in August 2018 and last updated November 18th 2022. Despite its closure, 1 additional trial is actively seeking individuals for their research."
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