Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye
Midhat H. Abdulreda
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.
Description
The American Diabetes Association reports that 38.4 million Americans had diabetes in 2021, which accounts for 11.6% of the population. About 77% of them were diagnosed (29.7 million) and the rest were undiagnosed (8.7 million). With an estimated 1.2 million new diagnoses every year, the number of people living with diabetes in the U.S. alone is estimated to increase by the end of the decade to 45.6 million. Approximately 95% of diabetics have type 2 diabetes (T2D) and the rest (\~2 million) are type 1 diabetics (T1D); although, the prevalence of T1D is also increasing. According to the Juveni…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Patients who meet all of the following criteria are eligible for participation in the study: Ophthalmic inclusion criteria: 1. Patient with at least one eye with extensive loss of vision from hand motion to no light perception. 2. Phakic or pseudophakic with a stable intraocular lens in the blind eye. 3. Normal cornea with good visualization of the anterior segment. 4. Normal anterior segment anatomy including the iris bed. General and metabolic inclusion criteria: 1. Male and female subjects ages 18 to 75 years of age and no history of non-compliance. 2. Clinical history compatible with T…
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 InstituteMiami, Florida
- Diabetes Research Institute, University of Miami Miller School of MedicineMiami, Florida