Clinical trial NCT02916680: Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study
Official title: Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Pancreatic islet transplantation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Absence of ophthalmic complications
timeFrame: 90 days
Secondary outcomes:
measure: Change in insulin production
timeFrame: 90 days
measure: Change in insulin requirements
timeFrame: 90 days
measure: Change in HbA1c
timeFrame: 90 days
measure: Change in fasting glucose
timeFrame: 90 days
measure: Change in total number of hypoglycemic events
timeFrame: 90 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Marc Y Donath, Prof.
role: PRINCIPAL_INVESTIGATOR
References: