Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye

Part of paid clinical trials in Miami, Florida.

Sponsor
Midhat H. Abdulreda
Study ID
NCT02846571
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 5, 2019
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
2 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Human Pancreatic Islet Transplantation
    Islet transplantation into the anterior chamber of the eye single arm

Primary Outcome Measure

Absence of ocular complications [ Time Frame: 24 months after transplant ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Bascom Palmer Eye InstituteMiamiFlorida33136
Sonia H. Yoo, M.D.
[email protected]
305-326-6000
Javier Paredes, CCRC
[email protected]
305-326-6387
Sonia H Yoo, M.D. (SUB_INVESTIGATOR)
Diabetes Research Institute, University of Miami Miller School of MedicineMiamiFlorida33136
Rodolfo Alejandro, M.D.
[email protected]
(305) 243-5324
David A Baidal, M.D.
[email protected]
(305) 243-7740
Rodolfo Alejandro, M.D. (SUB_INVESTIGATOR)
David A Baidal, M.D. (SUB_INVESTIGATOR)

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By research site
Bascom Palmer Eye Institute· Miami, FLDiabetes Research Institute, University of Miami Miller School of Medicine· Miami, FL

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