Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic islet transplantation | Experimental | Pancreatic islet transplantation in the anterior chamber of the human eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreatic islet transplantation in the anterior chamber | Procedure | Transplantation of allogeneic pancreatic islet cells into the anterior chamber of a severely visual impaired diabetic human eye |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of ophthalmic complications | safety | 90 days |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Y Donath, Prof. | Contact | 0041 61 265 50 78 | marc.donath@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Marc Y Donath, Prof. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016381 | Islets of Langerhans Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013507 |
| Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |