Islets of Langerhans TransplantationPhase 1/2NCT00579371
Cadaveric Islet Transplantation in Patients With Insulin-Dependent Diabetes Mellitus
A Phase 1/2 study testing Islets of Langerhans in people with Islets of Langerhans Transplantation and Diabetes Mellitus, Type 1, run by University of Nebraska at 1 site in United States.
Trial summary
We hypothesize that the following improvements to islet transplantation will increase the islet mass successfully isolated and allow for engraftment from a single pancreas. The improvements are: Using Two-Layer method preservation to improve pancreas quality before islet isolation Maintaining isolated islets in… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Islets of Langerhans Transplantation, Diabetes Mellitus, Type 1
- What is being tested?
- Islets of Langerhans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2004to Mar 2011
- Phase
- Phase 1/2
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group 1: Diagnosis of Type-1 diabetes mellitus for more than 5 years with at least one of the following complications:
- Metabolic lability/instability (two or more episodes of severe hypoglycemia) or two or more hospital visits for diabetic ketoacidosis during the previous year
- Progression of secondary complications of diabetes as determined by The Nebraska Medical Center/University of Nebraska Medical Center staff endocrinologists
- Group 2: Diagnosis of Type-1 diabetes with successful renal transplant on steroid-free, FK506/rapamycin-based immunosuppression
Who cannot join
- Severe co-existing cardiac disease
- Active alcohol or substance abuse, including cigarette smoking
- Psychiatric disorder making the subject not a suitable candidate for transplantation
- History of medical non-compliance
- Active infection, including hepatitis C and B, HIV, and tuberculosis (or suspected tuberculosis)
- Any history of malignancy except squamous or basal cell skin cancer
Show all 26Show fewer
- BMI >28 kg/meter-squared, or body weight >80kg at screening visit, or >85kg on the day of transplantation (due to the difficulty of obtaining a sufficiently large islet mass to adequately treat either large patients or those whose obesity elevates their insulin needs)
- Positive C-peptide response to intravenous glucose tolerance test and Mixed Meal glucose tolerance test: any C-peptide >0.3 ng/mL post infusion
- Inability to provide informed consent
- Age less than 19 or greater than 70 years
- Creatinine clearance <60 mL/min/1.73 meter-squared for Group 1 and creatinine clearance <40 mL/min/1.73 meter-squared for Group 2 (those subjects currently on immunosuppression due to previous kidney transplant)
- Macroalbuminuria (urinary albumin excretion rate >300 mg/24h) for Group 1 and macroalbuminuria (urinary albumin excretion rate >600mg/24h) for Group 2
- Baseline Hb <10 gm/dL
- Baseline liver function tests outside of normal range
- Presence of gallstones or hemangioma in liver on baseline ultrasound exam
- Positive pregnancy test, intention of future pregnancy, or presently breast-feeding
- Evidence of sensitization on panel reactive antibodies (PRA)
- Insulin requirement >0.7 IU/kg/day or HbA1c >15%
- Hyperlipidemia
- Under treatment for a medical condition requiring chronic use of steroids
- Use of Coumadin or other anticoagulant therapy (except aspirin) or a prothrombin time/international normalized ratio (PT-INR) >1.5
- Diagnosis of Addison's disease
- Additional Exclusion Criteria for Group 2 Subjects:
- Any history of organ transplantation other than kidney or pancreas
- Any previous graft lost to rejection
- Any history of early, multiple, or vascular renal allograft rejection
Trial locations and contacts
1 site in 1 country.
About this study
We hypothesize that the following improvements to islet transplantation will increase the islet mass successfully isolated and allow for engraftment from a single pancreas. The improvements are:
- Using Two-Layer method preservation to improve pancreas quality before islet isolation
- Maintaining isolated islets in culture before transplantation
- Using a steroid-free immunosuppression regimen
- Transplanting the best combination of donor and recipient possible after human leukocyte antigens (HLA) screening and final crossmatching
Read the detailed description
We hypothesize that the following improvements to islet transplantation will increase the islet mass successfully isolated and allow for engraftment from a single pancreas:
using Two-Layer method preservation to improve pancreas quality before islet isolation, maintaining isolated islets in culture before transplantation, using a steroid-free immunosuppression regimen, and transplanting the best combination of donor and recipient possible after HLA screening and final crossmatching.
- Being tested
- Islets of Langerhans
- Keywords
- islet transplantation, type 1 diabetes mellitus, steroid-free immunosuppression, rabbit anti-thymocyte globulin
- 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.
Islets of LangerhansDrug
Also called transplanted islets of Langerhans
Subjects will receive islets isolated from one donor pancreas per transplantation event. Subjects will receive a cumulative dose of 8,000IE/kg. Islets will be infused intraportally. If necessary, additional transplantation events will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Transplantation of Islets of Langerhans | Experimental | Subjects will receive islets isolated from one donor pancreas per transplantation event. Subjects will receive a cumulative dose of 8,000 International Units/kg. Islets will be infused intraportally. If necessary, additional transplantation events will be performed. Receives: Drug: Islets of Langerhans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of insulin independence with a single islet transplant
Incidence of insulin independence with a single transplantation measured at one year post-transplantation.
Measured: 1 year post-transplantation
Secondary outcomes (3)
Islet mass resulting in insulin independence/reduced exogenous insulin requirement
Insulin independence or reduced exogenous insulin required measured at one year post-transplantation.
Measured: 1 year post-transplantation
Graft survival
The survival of the Islets of Langerhans graft as measured at three years post-transplantation.
Measured: 3 years post-transplantation
Metabolic functional assessments of the islet graft
An assessment of the metabolic function of the islet of Langerhans graft as measured three years post-transplantation.
Measured: 3 years post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study start17 Mar 2004
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Per Coordinator: study was closed and no cadaveric implants were performed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Islets of Langerhans TransplantationStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- R Brian Stevens, MD PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579371
- Sponsor's protocol ID
- 0149-03-XX
- Other IDs
- BB IND 11397
- Status last verified
- Dec 2023
- First submitted
- 17 Dec 2007
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cadaveric Islet Transplantation in Patients With Insulin-Dependent Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00579371
- Acronym / sponsor ID
- 0149-03-XX
- Keywords
- islet transplantation, type 1 diabetes mellitus, steroid-free immunosuppression, rabbit anti-thymocyte globulin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per Coordinator: study was closed and no cadaveric implants were performed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 17 Mar 2004 (actual)
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 24 Dec 2007 (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.
We hypothesize that the following improvements to islet transplantation will increase the islet mass successfully isolated and allow for engraftment from a single pancreas. The improvements are:
- Using Two-Layer method preservation to improve pancreas quality before islet isolation
- Maintaining isolated islets in culture before transplantation
- Using a steroid-free immunosuppression regimen
- Transplanting the best combination of donor and recipient possible after human leukocyte antigens (HLA) screening and final crossmatching
Detailed description
We hypothesize that the following improvements to islet transplantation will increase the islet mass successfully isolated and allow for engraftment from a single pancreas:
using Two-Layer method preservation to improve pancreas quality before islet isolation, maintaining isolated islets in culture before transplantation, using a steroid-free immunosuppression regimen, and transplanting the best combination of donor and recipient possible after HLA screening and final crossmatching.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplantation of Islets of Langerhans | Experimental | Drug: Islets of LangerhansSubjects will receive islets isolated from one donor pancreas per transplantation event. Subjects will receive a cumulative dose of 8,000 International Units/kg. Islets will be infused intraportally. If necessary, additional transplantation events will be performed. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Group 1: Diagnosis of Type-1 diabetes mellitus for more than 5 years with at least one of the following complications:
- Group 2: Diagnosis of Type-1 diabetes with successful renal transplant on steroid-free, FK506/rapamycin-based immunosuppression
Key exclusion criteria (26 listed)
- Severe co-existing cardiac disease
- Active alcohol or substance abuse, including cigarette smoking
- Psychiatric disorder making the subject not a suitable candidate for transplantation
- History of medical non-compliance
- Active infection, including hepatitis C and B, HIV, and tuberculosis (or suspected tuberculosis)
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 |
|---|---|---|
| Islets of LangerhansAlso: transplanted islets of LangerhansSubjects will receive islets isolated from one donor pancreas per transplantation event. Subjects will receive a cumulative dose of 8,000IE/kg. Islets will be infused intraportally. If necessary, additional transplantation events will be performed. | Drug | Transplantation of Islets of Langerhans |
Primary outcome
Incidence of insulin independence with a single islet transplant
Time frame: 1 year post-transplantation
Incidence of insulin independence with a single transplantation measured at one year post-transplantation.
3 secondary outcomes
Islet mass resulting in insulin independence/reduced exogenous insulin requirement
Time frame: 1 year post-transplantation
Graft survival
Time frame: 3 years post-transplantation
Metabolic functional assessments of the islet graft
Time frame: 3 years post-transplantation
Results and safety
The study was stopped early (reason given: Per Coordinator: study was closed and no cadaveric implants were performed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
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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.
R Brian Stevens, MD PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Islets of Langerhans in people with Islets of Langerhans Transplantation and Diabetes Mellitus, Type 1, run by University of Nebraska 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 26 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: stopped early, as of the sponsor's last update on 21 Dec 2023. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Per Coordinator: study was closed and no cadaveric implants were performed). 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?
Incidence of insulin independence with a single islet transplant (time frame: 1 year post-transplantation). 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 21 Dec 2023.