Islet Isolation Using MnTE-2-PyP (BMX-010) - Pilot Study
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|ClinicalTrials.gov Identifier: NCT02457858|
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : September 30, 2016
In this study, the investigators hypothesize that the addition of antioxidant BMX-010 to perfusion solution, digestion solution and culture medium during islet isolation process, can lead to greater preservation of islet mass and metabolic function, such as improved islet yield, viability, and functional potency.
This pilot study will involve up to 10 participants from the islet transplant waiting list at the Clinical Islet Transplant Program. All participants will receive islets isolated with the medication BMX-010. This is to assess the primary safety of BMX-010 on pancreata and islets. BMX-010 will be used only in the islet isolation process, and will not be given to participants as medication.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: Islet isolation using BMX-010||Phase 1|
Islet Transplantation is a procedure used in people with difficult to control Type 1 Diabetes. Insulin producing cells (islets) are isolated from a deceased donor pancreas. After the cells are carefully isolated from the donor pancreas, the islets are transplanted into the recipient's liver. These transplanted islets may produce insulin.
One of the challenges with islet transplant is the death of some of the islet cells during isolation and storage while awaiting transplant. This is caused, in part, by inflammation and "oxidization" of the islet tissue. Oxidization is a process that causes chemical stress on living cells. We are looking for medications that would reduce inflammation, reduce oxidization and minimize cell death during the isolation process.
BMX-010 is a new drug that we believe will help fight oxidization. It is an antioxidant that has been shown in lab studies to help islet cells survive isolation and keep them healthy and functioning. BMX-010 has not been used in human islet transplants in Canada before this study. BMX-010 has been used once in a patient who needed his pancreas removed - the islets were isolated and treated with BMX-010, then transplanted back into the patient (auto-islet transplant). These results are promising and there have been no significant side-effects reported. There have also been studies using human islets, treated with BMX-010, transplanted into mice.
In this study, 10 patients will receive islets treated with BMX-010. This is to assess the primary safety of BMX-010 on pancreata and islets. For pancreata and islets treated with BMX-010, BMX-010 will be added in the steps of pancreas perfusion, pancreas digestion and islet culturing. Participants in the study will receive their islet transplants under standard of care islet transplant for all aspects of peri- and post-transplant management including immunosuppression. Islet transplant patients are followed as part of their standard of care, therefore the data collected for this study will be measured as part of routine clinical care, requiring no extra study specific clinic visits. We will review data collected up to day 30 post-transplant and will include the following: patient and graft survival data, biochemical data from routine blood work, routine and for cause imaging, metabolic testing, initiation of interventions to treat complications, and reporting of any adverse or serious adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Manganese Porphyrin MnTE-2-PyP (BMX - 010) Preservation of Islet Cell Mass and Function for Clinical Islet Transplantation|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: BMX-010 treated islets
Islet isolation using BMX-010
Drug: Islet isolation using BMX-010
BMX-010 will be used as a supplement in islet isolation process.
Other Name: MnTE-2-PyP
- Islet yield using BMX-010, compared to current standard islet isolation data [ Time Frame: Day -1 pre-transplant (Islet yield will be recorded as standard-of-care routine practice) ]To assess the safety of treating pancreata using BMX-010 prior to islet transplantation, treated islet isolation data will be measured and recorded, compared to current standard islet isolation data.
- Islet isolation quantity and quality using BMX-010, compared to current standard islet isolation data [ Time Frame: Day -1 pre-transplant (Islet isolation quantity and quality will be recorded as standard-of-care routine practice) ]To demonstrate efficacy of BMX-010 to improve islet isolation quantity and quality prior to islet transplantation, treated islet isolation data will be measured and recorded, compared to current standard islet isolation data.
- AE/SAE morbidity within 1 month post-transplant [ Time Frame: up to 1 month post-transplant ]To demonstrate safety of BMX-010 in islet transplantation, Adverse Event/Serious Adverse Event morbidity within 1 month post-transplant will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457858
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2C8|
|Principal Investigator:||James Shapiro, MD PhD||University of Alberta|