Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2025-04-30

Brief Summary

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The overall objective is to establish that transplantation of allogeneic pancreatic islet cells into the anterior chamber of a severely visual impaired diabetic human eye is safe and does not cause ophthalmic or systemic complications. Furthermore, the change in insulin production, glucose control and hypoglycaemia awareness will be assessed.

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Detailed Description

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Investigators intend to transplant 4 Type 1 Diabetes mellitus patients with compromised vision in one or both eyes due to diabetic or other complications, and who have already received kidney transplantation (i.e., already on immunosuppression). Transplantation of allogeneic pancreatic human islets will be performed into the anterior chamber of a single eye with compromised vision. Since the recipients are already immunosuppressed due to maintenance therapy for the kidney graft, investigators will only use non-steroidal anti-inflammatory drug (NSAID).

Only in case of uncontrolled reaction, steroid should be used under guidance of the ophthalmologists. Investigators will neither inject local immunosuppressive drugs nor change ongoing immunosuppressive medication in the pilot study.

The overall objective is to establish that transplantation of allogeneic pancreatic islet cells into the anterior chamber of a severely visual impaired diabetic human eye is safe and does not cause ophthalmic or systemic complications. Furthermore, the change in insulin production, glucose control and hypoglycaemia awareness will be assessed.

In this pilot study investigators aim to gain experience in the technique, to obtain preliminary data on the amount of insulin that can be expected per transplanted islet equivalent (IEQ) and observe possible local reactions. These data will help to design a future larger study in patients without visual impairment.

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pancreatic islet transplantation

Pancreatic islet transplantation in the anterior chamber of the human eye

Group Type EXPERIMENTAL

Pancreatic islet transplantation in the anterior chamber

Intervention Type PROCEDURE

Transplantation of allogeneic pancreatic islet cells into the anterior chamber of a severely visual impaired diabetic human eye

Interventions

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Pancreatic islet transplantation in the anterior chamber

Transplantation of allogeneic pancreatic islet cells into the anterior chamber of a severely visual impaired diabetic human eye

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Type 1 Diabetes (American Diabetes Association criteria)
2. Kidney transplant recipient with ongoing immunosuppression
3. At least one eye with extensive loss of vision from hand motion to no light perception due to damage of retina or optic nerve
4. Age ≥ 18 years
5. Normal cornea with good visualization of the anterior segment
6. Patient not eligible or with no wish for standard pancreatic islet into the hepatic portal system or pancreas transplantation