Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Type 1 Diabetes (NCT03977662) | Clinical Trial Compass
CompletedPhase 1/2
Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Type 1 Diabetes
United States4 participantsStarted 2019-07-01
Plain-language summary
The primary objective is to test the hypothesis that co-transplantation of allogeneic PTG with adult pancreatic islets (derived from same deceased donor) in the IM site in people with Type 1 diabetes with functioning kidney and/or liver transplants is safe, allows islet engraftment, and leads to insulin independence.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female subjects age 18 or older.
. Subjects who are able to provide written informed consent and to comply with study procedures.
. Clinical history compatible with Type 1 diabetes (onset \< 40 yrs old and insulin dependent for \> 5 yrs at enrollment, c-peptide negative).
. Recipients should have absent stimulated c-peptide (\< 0.3 ng/mL) in response to a (Boost® 6 mL/kg BW to a maximum of 360 mL; another equivalent product), measured at 60 and 90 min after start of consumption.
. Subjects who are \> 6 months post-renal transplant or \>6 months post-liver transplant who are taking appropriate calcineurin inhibitor (CNI) based maintenance immunosuppression (\[tacrolimus alone or in conjunction with sirolimus, mycophenolate mofetil, myfortic, or azathioprine; or cyclosporine in conjunction with sirolimus, mycophenolate mofetil, or myfortic ± Prednisone ≤ 10 mg/day).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events
Timeframe: Minimum of 1 year up to 2 years depending on transplant date
2
Incidence of post-transplant infections and malignancies
Timeframe: Minimum of 1 year up to 2 years depending on transplant date
3
Incidence of de novo sensitization
Timeframe: Minimum of 1 year up to 2 years depending on transplant date
4
Incidence of Insulin independence
Timeframe: Minimum of 1 year up to 2 years depending on transplant date
. Stable renal function as defined by a creatinine of no more than one third greater than the average creatinine determination performed in the 6 previous months prior to islet transplant, as well as absence of a rejection episode in the 6 months prior to islet transplant
. Stable liver function tests as defined by: SGOT (AST), SGPT (ALT), alkaline phosphatase values \< 1.5, or total bilirubin \< 1.5 times normal upper limits at time of study entry, as well as absence of a rejection episode in the 6 months prior to islet transplant
Exclusion criteria
. Presence of donor specific anti-HLA antibodies detected by Luminex Single Antigen/specificity bead assay including weakly reactive antibodies that would not be detected by a flow cross match
. Insulin requirement of \>1.0 IU/kg/day
. Weight more than 100 kg or body mass index (BMI) \> 30 kg/m2.
. Primary hyperparathyroidism OR secondary hyperparathyroidism
. Untreated or unstable proliferative diabetic retinopathy.
. Blood Pressure: SBP \> 180 mmHg or DBP \>100 mmHg despite treatment with antihypertensive agents.
. Calculated GFR of ≤ 40 mL/min/1.73 m2 using the subject's measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD- EPI) equation, as well as presence of a rejection episode in the 6 months prior to islet transplant
. Elevated liver function tests as defined by: SGOT (AST), SGPT (ALT), alkaline phosphatase values \> 1.5, or total bilirubin \>1.5 times normal upper limits at time of study entry, as well as presence of a rejection episode in the 6 months prior to islet transplant