Transplanting pancreatic islet cells into the eye for diabetes management
Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study
This study is testing if putting pancreatic cells into the eye can help people with Type 1 Diabetes who have serious vision problems manage their blood sugar better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT02916680 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the safety and efficacy of transplanting allogeneic pancreatic islet cells into the anterior chamber of the eye in patients with Type 1 Diabetes who have severe visual impairment. The study will involve four patients who have previously undergone kidney transplantation and are on immunosuppressive therapy. The researchers will monitor insulin production, glucose control, and hypoglycemia awareness following the transplantation. The goal is to gather preliminary data to inform future larger studies.
Who should consider this trial
Good fit: Ideal candidates are adults with Type 1 Diabetes who have undergone kidney transplantation and have significant vision loss.
Not a fit: Patients with uncontrolled diabetic retinopathy or poor visualization of the anterior chamber may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel method for improving insulin production and glucose control in patients with Type 1 Diabetes.
How similar studies have performed: While this approach is novel, similar studies involving islet transplantation have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Marc Y Donath, Prof. — University Hospital, Basel, Switzerland
- Study coordinator: Marc Y Donath, Prof.
- Email: marc.donath@usb.ch
- Phone: 0041 61 265 50 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.