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

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ClinicalTrials.gov Identifier: NCT02916680
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Procedure: Pancreatic islet transplantation in the anterior chamber Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study
Study Start Date : March 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Absence of ophthalmic complications [ Time Frame: 90 days ]
    safety


Secondary Outcome Measures :
  1. Change in insulin production [ Time Frame: 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

  2. Change in insulin requirements [ Time Frame: 90 days ]
    Change in insulin requirements: 3-day average daily insulin dose at baseline compared to Day 90 (Day 87 through Day 89)

  3. Change in HbA1c [ Time Frame: 90 days ]
    Change in HbA1c levels from baseline (Day 0 pre-transplant) at Day 90

  4. Change in fasting glucose [ Time Frame: 90 days ]
    Change in fasting glucose from baseline (Day 0 pre-transplant) at Day 90

  5. Change in total number of hypoglycemic events [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916680


Contacts
Contact: Marc Y Donath, Prof. 0041 61 265 50 78 marc.donath@usb.ch

Locations
Switzerland
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Marc Y Donath, Prof.    0041 61 265 50 78    marc.donath@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Marc Y Donath, Prof. University Hospital, Basel, Switzerland

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02916680     History of Changes
Other Study ID Numbers: Eye ITPL
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Basel, Switzerland:
Pancreatic islet transplantation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases