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

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Procedure: Pancreatic islet transplantation in the anterior chamber

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 Type: Interventional
• Enrollment (Estimated): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Y Donath, Prof.; Phone Number: 0041 61 265 50 78; Email: marc.donath@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel
    • Contact: Marc Y Donath, Prof.; Phone Number: 0041 61 265 50 78; Email: marc.donath@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pancreatic islet transplantation; Pancreatic islet transplantation in the anterior chamber of the human eye	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of ophthalmic complications	safety	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in HbA1c	Change in HbA1c levels from baseline (Day 0 pre-transplant) at Day 90	90 days
Change in fasting glucose	Change in fasting glucose from baseline (Day 0 pre-transplant) at Day 90	90 days
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Marc Y Donath, Prof., University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: September 26, 2016
• First Posted (Estimated): September 27, 2016

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pancreatic islet transplantation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Eye ITPL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO