Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 31, 2016
CompletedFirst Posted
Study publicly available on registry
September 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedMarch 29, 2024
March 1, 2024
9.1 years
March 31, 2016
March 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absence of ophthalmic complications
safety
90 days
Secondary Outcomes (5)
Change in insulin production
90 days
Change in insulin requirements
90 days
Change in HbA1c
90 days
Change in fasting glucose
90 days
Change in total number of hypoglycemic events
90 days
Study Arms (1)
Pancreatic islet transplantation
EXPERIMENTALPancreatic islet transplantation in the anterior chamber of the human eye
Interventions
Transplantation of allogeneic pancreatic islet cells into the anterior chamber of a severely visual impaired diabetic human eye
Eligibility Criteria
You may qualify if:
- Type 1 Diabetes (American Diabetes Association criteria)
- Kidney transplant recipient with ongoing immunosuppression
- At least one eye with extensive loss of vision from hand motion to no light perception due to damage of retina or optic nerve
- Age ≥ 18 years
- Normal cornea with good visualization of the anterior segment
- Patient not eligible or with no wish for standard pancreatic islet into the hepatic portal system or pancreas transplantation
You may not qualify if:
- Uncontrolled diabetic retinopathy
- Signs of current infection
- Poor visualization of the anterior chamber
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Basel
Basel, 4031, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Y Donath, Prof.
University Hospital, Basel, Switzerland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2016
First Posted
September 27, 2016
Study Start
March 1, 2016
Primary Completion
April 1, 2025
Study Completion
April 1, 2025
Last Updated
March 29, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share