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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Luxa Biotechnology, LLCLead Sponsor

National Institutes of Health (NIH)NIH

2,700 Previous Clinical Trials

7,506,858 Total Patients Enrolled

National Eye Institute (NEI)NIH

546 Previous Clinical Trials

1,401,901 Total Patients Enrolled

Media Library

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of enrolment for this clinical research?

"Affirmative. Information on clinicaltrials.gov demonstrates that this medical experiment, which was initially registered on April 5th 2022, is actively seeking participants. Specifically 18 people need to be enrolled at one site of the trial."

Answered by AI

Are individuals currently being accepted into this research endeavor?

"Affirmative. According to the information found on clinicaltrials.gov, this medical trial is currently looking for research participants and was initially posted on April 5th 2022. The most recent update of the study took place on July 24th 2022, requiring 18 test subjects from a single centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)

2022. "Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04627428.