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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02916680
• Other study ID #: Eye ITPL
• Status: Recruiting
• Phase: N/A
• Start date: March 2016
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Marc Y Donath, Prof.
• Phone: 0041 61 265 50 78
• Email: marc.donath[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of ophthalmic complications	safety	90 days
Secondary	Change in insulin production	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	90 days
Secondary	Change in insulin requirements	Change in insulin requirements: 3-day average daily insulin dose at baseline compared to Day 90 (Day 87 through Day 89)	90 days
Secondary	Change in HbA1c	Change in HbA1c levels from baseline (Day 0 pre-transplant) at Day 90	90 days
Secondary	Change in fasting glucose	Change in fasting glucose from baseline (Day 0 pre-transplant) at Day 90	90 days
Secondary	Change in total number of hypoglycemic events	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)	90 days