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New treatment option for Diabetes Mellitus, Type 1
Official title Islet Transplantation in Type 1 Diabetic Kidney Allograft
ClinicalTrials.gov ID: NCT01241864
What this study is testing
What is Allogenic islet cells (human, U. Chicago)?
Allogenic islet cells (human, U. Chicago) is an investigational medicine, being studied as a potential treatment for diabetes mellitus, type 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to learn about the safety of islet transplantation when performed after kidney transplantation, which may provide more normal control of blood sugar without the need for insulin shots. Islets are special clusters of cells within the pancreas that produce insulin.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 68
You may be able to join if
- Male and female people age 18 to 68 years.
- people who are able to provide written informed consent and to comply with the procedures of the study protocol.
- Clinical history compatible with T1D with disease onset \ 5 years at the time of enrollment, and a sum of subject age and insulin dependent diabetes...
- Absent stimulated c-peptide (\< 0.3 ng/mL) in response to a MMTT [Boost® 6 mL/kg body weight (BW) to a maximum of 360 mL; another product with...
- people who are \> or at 3 months post-renal transplant who are taking appropriate calcineurin inhibitor (CNI) based maintenance immunosuppression...
You likely can't join if
- Weight more than 90 kg or body mass index (BMI) \> 30 kg/m2.
- Insulin requirement of \>1.0 IU/kg/day or \<15 U/day.
- Other (non-kidney) organ transplants except prior failed pancreatic graft where the graft failed within the first two weeks due to thrombosis...
- Untreated or unstable proliferative diabetic retinopathy.
- Blood Pressure: SBP \> 160 mmHg or DBP \>100 mmHg despite treatment with antihypertensive agents.
- Calculated GFR \< 40 mL/min/1.73 m2 using the subject's measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)...
See the full eligibility criteria
- Male and female people age 18 to 68 years.
- people who are able to provide written informed consent and to comply with the procedures of the study protocol.
- Clinical history compatible with T1D with disease onset \ 5 years at the time of enrollment, and a sum of subject age and insulin dependent diabetes duration of \> 28.
- Absent stimulated c-peptide (\< 0.3 ng/mL) in response to a MMTT [Boost® 6 mL/kg body weight (BW) to a maximum of 360 mL; another product with equivalent caloric and nutrient content may be substituted for Boost®]...
- people who are \> or at 3 months post-renal transplant who are taking appropriate calcineurin inhibitor (CNI) based maintenance immunosuppression ([tacrolimus alone or in conjunction with sirolimus, mycophenolate...
- Stable renal function as defined by a creatinine of no more than one third greater than the average creatinine determination performed in the 3 previous months prior to islet transplantation, until rejection...
- Weight more than 90 kg or body mass index (BMI) \> 30 kg/m2.
- Insulin requirement of \>1.0 IU/kg/day or \<15 U/day.
- Other (non-kidney) organ transplants except prior failed pancreatic graft where the graft failed within the first two weeks due to thrombosis, followed by pancreatectomy; with the pancreas transplant occurring more than...
- Untreated or unstable proliferative diabetic retinopathy.
- Blood Pressure: SBP \> 160 mmHg or DBP \>100 mmHg despite treatment with antihypertensive agents.
- Calculated GFR \< 40 mL/min/1.73 m2 using the subject's measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation [1]. Strict vegetarians (vegans) will be excluded only if...
- Proteinuria (albumin/ creatinine ratio or ACr \> 300mg/g) of new onset since kidney transplantation.
- Either Class I or Class II panel-reactive anti-HLA antibodies \> 50%. people with either Class I or Class II panel reactive anti-HLA antibodies \>50% will be excluded if any of the following are detected: Positive...
- For female people: Positive pregnancy test, presently breast-feeding, desires to be pregnant at any time point in the future, which includes during or after the completion of the study even if study participation is...
- Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB). people with laboratory evidence of active infection are excluded even in the absence of clinical evidence of active...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 68 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.