RecruitingPhase 1Phase 2NCT02846571

Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye


Sponsor

Midhat H. Abdulreda

Enrollment

2 participants

Start Date

Dec 5, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The intervention in this trial is intraocular islet transplantation. A single dose of 1000 - 3000 Islet Equivalents (IEQ)/kg recipient body weight (BW) will be infused into the anterior chamber of the eye through a self-sealing incision in the peripheral cornea. The procedure is projected to take approximately 20-30 minutes. Transplant recipients in this study will receive localized maintenance immunosuppression via topical application of eye-drops.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether insulin-producing cells from the pancreas (called islet cells) can be safely transplanted into the front chamber of the eye in patients with diabetes who have already lost vision in one eye, potentially creating a new, easily monitored site for transplantation. **You may be eligible if...** - You have at least one eye that has extensive vision loss ranging from only seeing hand movements to complete blindness - The lens in your blind eye is stable (natural or a previously placed artificial lens) - The front of your eye appears structurally normal - You are between 18 and 75 years old - You have type 1 or type 2 diabetes, with or without insulin use - Your kidney function is stable - You are able to provide written informed consent **You may NOT be eligible if...** - Both eyes still have useful vision - You have eye anatomy problems that would make the procedure unsafe - You have unstable kidney function - You are unable to comply with required follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHuman Pancreatic Islet Transplantation

Human pancreatic islet transplantation in the eye anterior chamber of legally blind type 1 or type 2 diabetes patients with and without insulin-dependence


Locations(2)

Bascom Palmer Eye Institute

Miami, Florida, United States

Diabetes Research Institute, University of Miami Miller School of Medicine

Miami, Florida, United States

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NCT02846571


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