Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye

Who is this study for? Adult patients with type 1 diabetes
What treatments are being studied? Human Pancreatic Islet Transplantation
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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. Subject will remain flat on their back for 1 - 3 hours after islet infusion to maximize adhesion of the islets to the iris.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Patient with at least one eye with extensive loss of vision from hand motion to no light perception.

• Phakic or pseudophakic with a stable intraocular lens in the blind eye.

• Normal cornea with good visualization of the anterior segment.

• Normal anterior segment anatomy including the iris bed.

• Male and female subjects ages 18 to 75 years of age and no history of non-compliance.

• Clinical history compatible with T1D or T2D with or without insulin-dependence at the time of enrollment.

• Stable renal function of native or transplanted kidney if applicable.

• Ability to provide written informed consent.

• Mentally stable and able to comply with the procedures of the study protocol.

Locations
United States
Florida
Bascom Palmer Eye Institute
RECRUITING
Miami
Diabetes Research Institute, University of Miami Miller School of Medicine
RECRUITING
Miami
Contact Information
Primary
Midhat H Abdulreda, Ph.D.
mabdulreda@miami.edu
305-243-9871
Backup
Sonia Yoo, M.D.
syoo@med.miami.edu
305-326-6000
Time Frame
Start Date: 2019-12-05
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 2
Treatments
Other: Human Pancreatic Islet Transplantation
Islet transplantation into the anterior chamber of the eye single arm
Authors
Midhat Abdulreda, Rodolfo Alejandro
Sponsors
Collaborators: Bascom Palmer Eye Institute, Diabetes Research Institute Foundation
Leads: Midhat H. Abdulreda

This content was sourced from clinicaltrials.gov