Type 1 Diabetes MellitusNCT02916680
Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study
A study testing Pancreatic islet transplantation in the anterior chamber in people with Type 1 Diabetes Mellitus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Pancreatic islet transplantation in the anterior chamber
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2016to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Uncontrolled diabetic retinopathy
- Signs of current infection
- Poor visualization of the anterior chamber
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Marc Y Donath, Prof., 0041 61 265 50 78, marc.donath@usb.ch
About this 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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Pancreatic islet transplantation in the anterior chamber
- Keywords
- Pancreatic islet transplantation
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic islet transplantation in the anterior chamberProcedure or surgery
Transplantation of allogeneic pancreatic islet cells into the anterior chamber of a severely visual impaired diabetic human eye
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic islet transplantation | Experimental | Pancreatic islet transplantation in the anterior chamber of the human eye Receives: Procedure: Pancreatic islet transplantation in the anterior chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of ophthalmic complications
safety
Measured: 90 days
Secondary outcomes (5)
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
Measured: 90 days
Change in insulin requirements
Change in insulin requirements: 3-day average daily insulin dose at baseline compared to Day 90 (Day 87 through Day 89)
Measured: 90 days
Change in HbA1c
Change in HbA1c levels from baseline (Day 0 pre-transplant) at Day 90
Measured: 90 days
Change in fasting glucose
Change in fasting glucose from baseline (Day 0 pre-transplant) at Day 90
Measured: 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)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Y Donath, Prof., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916680
- Sponsor's protocol ID
- Eye ITPL
- Status last verified
- Mar 2024
- First submitted
- 31 Mar 2016
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study
- ClinicalTrials.gov ID
- NCT02916680
- Acronym / sponsor ID
- Eye ITPL
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Pancreatic islet transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic islet transplantation | Experimental | Procedure: Pancreatic islet transplantation in the anterior chamberPancreatic islet transplantation in the anterior chamber of the human eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Uncontrolled diabetic retinopathy
- Signs of current infection
- Poor visualization of the anterior chamber
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreatic islet transplantation in the anterior chamberTransplantation of allogeneic pancreatic islet cells into the anterior chamber of a severely visual impaired diabetic human eye | Procedure or surgery | Pancreatic islet transplantation |
Primary outcome
Absence of ophthalmic complications
Time frame: 90 days
safety
5 secondary outcomes
Change in insulin production
Time frame: 90 days
Change in insulin requirements
Time frame: 90 days
Change in HbA1c
Time frame: 90 days
Change in fasting glucose
Time frame: 90 days
Change in total number of hypoglycemic events
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Y Donath, Prof. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreatic islet transplantation in the anterior chamber in people with Type 1 Diabetes Mellitus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Y Donath, Prof. (0041 61 265 50 78, marc.donath@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of ophthalmic complications (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.