Diabetes Mellitus, Type 1Phase 1NCT00605592
UVA Islet Cell Transplantation in Patients With Type I Diabetes
A Phase 1 study testing Pancreatic Islets of Langerhans Cell Transplant in people with Diabetes Mellitus, Type 1, run by University of Virginia at 1 site in United States.
Trial summary
This protocol will provide islet cell transplantation to two separate populations in need of a pancreas transplant: Group I: Islet Cell Transplantation in Type I Diabetics without Kidney Problems Group II: Islet Cell Transplantation in Type I Diabetics Who Have a Stable Functioning Kidney Transplant The targeted… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Pancreatic Islets of Langerhans Cell Transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jan 2012
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type I Diabetes Mellitus for at least 5 years
- Unstable control of diabetes despite intensive care by an endocrinologist, including episodes of dangerously low blood sugars
- Group I must have healthy kidneys
- Group II (islet after kidney) must have a stable kidney allograft for at least 6 months
Who cannot join
- Unstable diabetic eye disease
- Poor kidney function
- Type II Diabetes as determined by blood tests
- Any history of cancer, except certain skin cancers
- Pregnant or unwilling to use adequate birth control
- Very high hemoglobin A1c levels
Show all 10Show fewer
- Poor control of blood pressure, despite use of medications
- Very high insulin requirements
- History of exposure to HIV
- Active Hepatitis B or Hepatitis C infection
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
This protocol will provide islet cell transplantation to two separate populations in need of a pancreas transplant:
Group I: Islet Cell Transplantation in Type I Diabetics without Kidney Problems
Read more
Group II: Islet Cell Transplantation in Type I Diabetics Who Have a Stable Functioning Kidney Transplant
The targeted patients have very brittle diabetes or dangerous hypoglycemic unawareness and may benefit from transplantation over continuing insulin therapy, even though chronic immunosuppression is required. We believe that in these patients, the islet transplant procedure promises enough potential benefit to justify subjecting patients who have not previously had a transplant to the risk of immunosuppression.
In patients who are already subject to the dangers of chronic immunosuppression for other reasons, i.e. to prevent rejection of a kidney allograft, the islet transplantation procedure itself is the principal additional risk and this risk should be minimal. In these patients (our Group II), the potential benefit from improved glycemic control is that it promises to slow or even reverse diabetic complications, such as vascular problems leading to kidney damage. It is this rationale that has made pancreas transplantation a widely accepted option in patients with renal failure, despite the risks associated with whole pancreas transplantation. Islet cell transplantation aims to provide a potentially lower risk procedure that has similar relief from diabetic complications.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Pancreatic Islets of Langerhans Cell Transplant
- Keywords
- Type 1 Diabetes, Kidney Transplant, Hypoglycemic Unawareness, Islet Transplant, Pancreatic Islet Cell Transplantation, University of Virginia, Islet Transplantation, Kidney 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 Islets of Langerhans Cell TransplantProcedure or surgery
Also called Islet Cell Transplant, Pancreatic Islet Cell Transplantation
Transplantation of islet cells will be given to eligible patients, up to three times during the study, using cell quantities based on body weight.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Islet cell transplant Receives: Procedure: Pancreatic Islets of Langerhans Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
A decrease in the average daily insulin requirement post-islet cell transplantation.
Measured: Post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- Kenneth Brayman, MD, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605592
- Sponsor's protocol ID
- 12839
- Status last verified
- Feb 2009
- First submitted
- 18 Jan 2008
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UVA Islet Cell Transplantation in Patients With Type I Diabetes
- ClinicalTrials.gov ID
- NCT00605592
- Acronym / sponsor ID
- 12839
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 Diabetes, Kidney Transplant, Hypoglycemic Unawareness, Islet Transplant, Pancreatic Islet Cell Transplantation, University of Virginia, Islet Transplantation, Kidney Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Jan 2007
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 31 Jan 2008 (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.
This protocol will provide islet cell transplantation to two separate populations in need of a pancreas transplant:
Group I: Islet Cell Transplantation in Type I Diabetics without Kidney Problems
Group II: Islet Cell Transplantation in Type I Diabetics Who Have a Stable Functioning Kidney Transplant
The targeted patients have very brittle diabetes or dangerous hypoglycemic unawareness and may benefit from transplantation over continuing insulin therapy, even though chronic immunosuppression is required. We believe that in these patients, the islet transplant procedure promises enough potential benefit to justify subjecting patients who have not previously had a transplant to the risk of immunosuppression.
In patients who are already subject to the dangers of chronic immunosuppression for other reasons, i.e. to prevent rejection of a kidney allograft, the islet transplantation procedure itself is the principal additional risk and this risk should be minimal. In these patients (our Group II), the potential benefit from improved glycemic control is that it promises to slow or even reverse diabetic complications, such as vascular problems leading to kidney damage. It is this rationale that has made pancreas transplantation a widely accepted option in patients with renal failure, despite the risks associated with whole pancreas transplantation. Islet cell transplantation aims to provide a potentially lower risk procedure that has similar relief from diabetic complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Pancreatic Islets of Langerhans Cell TransplantIslet cell transplant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type I Diabetes Mellitus for at least 5 years
- Unstable control of diabetes despite intensive care by an endocrinologist, including episodes of dangerously low blood sugars
- Group I must have healthy kidneys
- Group II (islet after kidney) must have a stable kidney allograft for at least 6 months
Key exclusion criteria (10 listed)
- Unstable diabetic eye disease
- Poor kidney function
- Type II Diabetes as determined by blood tests
- Any history of cancer, except certain skin cancers
- Pregnant or unwilling to use adequate birth control
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 Islets of Langerhans Cell TransplantAlso: Islet Cell Transplant, Pancreatic Islet Cell TransplantationTransplantation of islet cells will be given to eligible patients, up to three times during the study, using cell quantities based on body weight. | Procedure or surgery | 1 |
Primary outcome
A decrease in the average daily insulin requirement post-islet cell transplantation.
Time frame: Post-transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
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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.
Kenneth Brayman, MD, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pancreatic Islets of Langerhans Cell Transplant in people with Diabetes Mellitus, Type 1, run by University of Virginia at 1 site in United States.
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 4 inclusion and 10 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 18 Feb 2009. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A decrease in the average daily insulin requirement post-islet cell transplantation. (time frame: Post-transplant). 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 18 Feb 2009.