Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study

University Hospital Basel

Status: Enrolling

Conditions: Type 1 Diabetes Mellitus

Treatments: Procedure: Pancreatic islet transplantation in the anterior chamber

Study type: Interventional

Funder types: Other

Identifiers

NCT02916680

Eye ITPL

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

1. Uncontrolled diabetic retinopathy
2. Signs of current infection
3. Poor visualization of the anterior chamber

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Pancreatic islet transplantation

Experimental group

Description:

Pancreatic islet transplantation in the anterior chamber of the human eye

Treatment:

Procedure: Pancreatic islet transplantation in the anterior chamber