Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye
NCT02846571 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2026-03-12
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.
Conditions
Interventions
- BIOLOGICAL
-
Human 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
Sponsors & Collaborators
-
Diabetes Research Institute Foundation
collaborator OTHER -
Bascom Palmer Eye Institute
collaborator OTHER -
Midhat H. Abdulreda
lead OTHER
Principal Investigators
-
Midhat H Abdulreda, Ph.D. · University of Miami
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-12-05
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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