Device-Less Technique in Islet Transplantation
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|ClinicalTrials.gov Identifier: NCT05073302|
Recruitment Status : Recruiting
First Posted : October 11, 2021
Last Update Posted : May 12, 2022
Islet transplantation is an effective modality for treating type 1 diabetes. Despite marked progress in clinical islet transplantation with the achievement and maintenance of insulin independence in over half of recipients up to 5 years, transplant approaches are limited to those that struggle to control their diabetes. Furthermore, this approach remains restricted due to the scarcity of human pancreas donors. While transplanting insulin-producing cells into the liver has been demonstrated as an efficacious means of restoring glycemic control to patients with T1D, the procedure often results in cell loss, and carries risks. Moreover, transplant in to the liver does not permit imaging or retrieval of donor islets. The ability to retrieve the cells is also important for safety reasons.
In theory, the space under the skin is an attractive alternate site for transplanting insulin producing cell, due to ready access, and potential for monitoring cellular transplant function through novel imaging techniques. However, transplantation of insulin producing cells into an unmodified site under the skin universally fails to reverse diabetes in research animal models, or in human studies. Other techniques using devices with different type of technologies and biomaterials have been explored with variable success. Unfortunately, the foreign body and inflammatory reaction persist in the implant. Shapiro Lab, has developed a novel technique called 'device-less' (DL) transplant modality. This approach was designed to harness an innate foreign body response in a favorable and controlled manner, to induce growth of new blood vessels to allow the survival of the insulin producing cells without the natural body response to foreign body. Briefly, this site transforms the inhospitable under the skin site into a viable location through the temporary implantation of a small tube called angiocatheter.
For this study, 5 patients will received transplant in to the modified site under the skin using the DL transplant technique.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Procedure: Implantation of Nylon catheter (Device-less sentinel unit)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Test a new biomedical intervention in a small group of people for the first time to evaluate safety (e.g. to determine a safe dosage range and to identify side effects)|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial Evaluating a Device-Less Technique in Islet Transplantation|
|Actual Study Start Date :||March 22, 2022|
|Estimated Primary Completion Date :||January 30, 2024|
|Estimated Study Completion Date :||January 30, 2024|
Experimental: Treatment Group
Implantation of the Device-Less sentinel units. Ultrasound Monitoring. Islet Transplantation. Explantation of Device-Less Sentinels. Standard of Care. Concomitant Care. Post Transplant Testing and Visits. Participant Retention (nine month follow up assessment).
Procedure: Implantation of Nylon catheter (Device-less sentinel unit)
Implantation of the Device-Less sentinel units. Ultrasound monitoring will be performed after Device-Less implantation. Standard Islet cell Transplantation: Will occur simultaneously Portal islet transplantation and subcutaneous islet transplantation in the Device-Less sentinel spaces.
Islets are maintained for a minimum of 6 hours up to 72 hours in supplemented CMRL1066-based media until the time of transplant.
Concomitant to portal vein infusion, islet transplantation will occur in all four (4) DL sentinel spaces.
To explant a unit, the Surgeon will make an incision and then carefully dissect the tissue engrafted around the transplant. The entire transplant site and any adherent tissue capsule can then be removed entirely from the pocket.
- Rate of Adverse Events/Serious Adverse Events [ Time Frame: 9 months ]Adverse Events/ Serious Adverse Event experienced by the participants in the study
- Rate of inflammation in the DL implant site [ Time Frame: 9 months ]Implant tolerability assessment
- Probability of rejection or injury analyzed using the Molecular Microscope Diagnostic System (MMDx) system by measuring the expressions of all genes within the graft [ Time Frame: 9 months ]Molecular Microscope Diagnostic System (MMDx) of the explanted tissue
- Percentage of live cells measured by immunohistochemistry [ Time Frame: 9 months ]
- Presence of vascularization demonstrated by immunohistochemistry [ Time Frame: 9 months ]
- Presence of immune response demonstrated by immunohistochemistry [ Time Frame: 9 months ]
- Cellular composition demonstrated by immunohistochemistry [ Time Frame: 9 months ]
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): NCT05073302
|Contact: Saira Qureshi, BScfirstname.lastname@example.org|
|Contact: Parastoo Dinyari, BScemail@example.com|
|University of Alberta Clinical Islet Transplant Program||Recruiting|
|Edmonton, Alberta, Canada, T6G 2E1|
|Contact: Andrew J Shapiro, MD (780) 492-3974 firstname.lastname@example.org|
|Contact: Rayna Bahneva 780-492-5727 email@example.com|
|Principal Investigator: Andrew J Shapiro, MD|
|Sub-Investigator: Andrew Pepper, PhD|
|Sub-Investigator: Peter Senior, MD|
|Principal Investigator:||James Shapiro, MD, PhD||University of Alberta|