Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02916680|
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : May 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Procedure: Pancreatic islet transplantation in the anterior chamber||Not Applicable|
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)|
|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|
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
- Absence of ophthalmic complications [ Time Frame: 90 days ]safety
- 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
- 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)
- Change in HbA1c [ Time Frame: 90 days ]Change in HbA1c levels from baseline (Day 0 pre-transplant) at Day 90
- Change in fasting glucose [ Time Frame: 90 days ]Change in fasting glucose from baseline (Day 0 pre-transplant) at Day 90
- 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)
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
|Contact: Marc Y Donath, Prof.||0041 61 265 50 email@example.com|
|University Hospital Basel||Recruiting|
|Basel, Switzerland, 4031|
|Contact: Marc Y Donath, Prof. 0041 61 265 50 78 firstname.lastname@example.org|
|Principal Investigator:||Marc Y Donath, Prof.||University Hospital, Basel, Switzerland|