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

Not Applicable

Recruiting

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Procedure: Pancreatic islet transplantation in the anterior chamber

• Registration Number: NCT02916680
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pancreatic islet transplantation	Pancreatic islet transplantation in the anterior chamber	Pancreatic islet transplantation in the anterior chamber of the human eye

Primary Outcome Measures

Name	Time	Method
Absence of ophthalmic complications	90 days	safety

Secondary Outcome Measures

Name	Time	Method
Change in total number of hypoglycemic events	90 days	Change in total number of hypoglycemic events 3-day average at baseline compared to Day 90 (Day 87 through Day 89) as assessed by continuous glucose monitoring (CGMS)
Change in HbA1c	90 days	Change in HbA1c levels from baseline (Day 0 pre-transplant) at Day 90
Change in insulin requirements	90 days	Change in insulin requirements: 3-day average daily insulin dose at baseline compared to Day 90 (Day 87 through Day 89)
Change in insulin production	90 days	Change in insulin production as derived from change in C-peptide, insulin, pro-insulin and glucose levels during the mixed meal tolerance test (MMTT) at Day 90 compared to baseline
Change in fasting glucose	90 days	Change in fasting glucose from baseline (Day 0 pre-transplant) at Day 90

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland