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Stem Cell Therapy

Stem Cell Therapy for Dry Age-Related Macular Degeneration

Phase 1 & 2
Recruiting
Led By Rajesh C Rao, M.D.
Research Sponsored by Luxa Biotechnology, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to understand and give informed consent
Medically suitable to undergo vitrectomy and subretinal injection (>60% on Karnofsky scale)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will test if a new drug is safe and tolerated by people with dry age-related macular degeneration.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests the safety and tolerability of a stem cell-derived treatment called RPESC-RPE-4W in patients with dry age-related macular degeneration (AMD). It involves vitrectomy and subretinal injection procedures to deliver the therapy.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical risks associated with vitrectomy and subretinal injections such as eye inflammation, infection risk increase, vision changes, bleeding inside the eye area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand the study and agree to participate.
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I am medically fit for eye surgery (>60% Karnofsky).
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I have been diagnosed with dry age-related macular degeneration.
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I am over 55 years old.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of RPESC-RPE-4W transplantation
Secondary outcome measures
Change in GA lesion area
Change in the mean of Best Corrected Visual Acuity (BCVA)
Evidence of structural changes
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: 50,000 cellsExperimental Treatment1 Intervention
Six patients will receive single dose of 50,000 RPESC-RPE-4W cells in the eye.
Group II: 250,000 cellsExperimental Treatment1 Intervention
Six patients will receive single dose of 250,000 RPESC-RPE-4W cells in the eye.
Group III: 150,000 cellsExperimental Treatment1 Intervention
Six patients will receive single dose of 150,000 RPESC-RPE-4W cells in the eye.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF (vascular endothelial growth factor) therapy, photodynamic therapy, and emerging treatments like Retinal Pigment Epithelial (RPE) cell transplantation. Anti-VEGF therapy works by inhibiting abnormal blood vessel growth and leakage in the retina, which helps to prevent vision loss. Photodynamic therapy involves using a light-activated drug to destroy abnormal blood vessels. RPE cell transplantation, such as the RPESC-RPE-4W being studied, aims to replace damaged RPE cells, which are crucial for supporting the photoreceptors in the retina. This is particularly important for AMD patients as it addresses the underlying cellular damage, potentially restoring retinal function and slowing disease progression.

Find a Location

Who is running the clinical trial?

Luxa Biotechnology, LLCLead Sponsor
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,428 Total Patients Enrolled
National Eye Institute (NEI)NIH
547 Previous Clinical Trials
1,402,025 Total Patients Enrolled

Media Library

Age-Related Macular Degeneration Clinical Trial 2023: RPESC-RPE-4W Highlights & Side Effects. Trial Name: NCT04627428 — Phase 1 & 2
~5 spots leftby May 2025
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