Stem Cell Therapy for Dry Age-Related Macular Degeneration
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new treatment where cells from donor eyes are transplanted into patients with dry AMD to see if it is safe and can help improve their vision. Stem cell transplantation may improve visual acuity in patients with dry age-related macular degeneration.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressant therapy, you must not have taken it in the past six months to participate.
Is stem cell therapy for dry age-related macular degeneration safe?
Research shows that stem cell therapy using retinal pigment epithelial cells derived from embryonic stem cells has been generally safe in early trials, with no serious adverse effects reported in humans, except for one case of infection after surgery. Animal studies also found no obvious negative reactions, suggesting the treatment is well-tolerated.12345
How is the treatment RPESC-RPE-4W different from other treatments for dry age-related macular degeneration?
RPESC-RPE-4W is unique because it involves using stem cells to generate retinal pigment epithelium (RPE) cells, which are then transplanted into the eye to potentially restore vision in patients with dry age-related macular degeneration, a condition with no effective treatments currently available.56789
What data supports the effectiveness of the treatment RPESC-RPE-4W for dry age-related macular degeneration?
Research shows that stem cell-derived retinal pigment epithelial (RPE) cells, similar to those in RPESC-RPE-4W, have been successfully transplanted in patients with age-related macular degeneration, maintaining vision and being well tolerated. Additionally, clinical trials have shown promising outcomes in restoring visual function by transplanting these cells into the eye.25679
Who Is on the Research Team?
David S Liao, MD, PhD
Principal Investigator
Retina-Vitreous Associates Medical Group
Theodore Leng, MD, FACS
Principal Investigator
Spencer Center for Vision Research at Stanford University
Rajesh C Rao, M.D.
Principal Investigator
University of Michigan Kellogg Eye Center
Are You a Good Fit for This Trial?
This trial is for adults over 55 with dry AMD who can consent and are healthy enough for eye surgery. Men must use contraception, women should be postmenopausal or unable to have children. Excluded are those with major health issues, recent immunosuppressants or clinical trials, certain infections, pregnancy, nursing, or specific allergies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of RPESC-RPE-4W cells in the eye, with doses varying from 50,000 to 250,000 cells
Follow-up
Participants are monitored for safety and effectiveness after treatment, including visual acuity and structural changes
What Are the Treatments Tested in This Trial?
Interventions
- RPESC-RPE-4W
Find a Clinic Near You
Who Is Running the Clinical Trial?
Luxa Biotechnology, LLC
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Eye Institute (NEI)
Collaborator
Regenerative Research Foundation
Collaborator