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Procedure
Device-Less Islet Transplantation for Type 1 Diabetes
Phase 1
Recruiting
Led By James Shapiro, MD, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new method of transplanting insulin-producing cells under the skin for people with type 1 diabetes who struggle with standard treatments. The technique uses a small tube to create a supportive environment for the cells. This approach aims to improve blood sugar control by helping the transplanted cells survive and function effectively. This method is being explored as an alternative to insulin therapy, especially for those with severe blood sugar issues.
Who is the study for?
This trial is for adults with Type 1 Diabetes who have unstable blood sugar levels, frequent hospital visits due to diabetic ketoacidosis, or reduced awareness of hypoglycemia. They must understand the study and consent to participate. Excluded are those under 18 or over 68, with certain medical conditions like severe heart disease, kidney issues, psychiatric disorders, high insulin requirements, pregnancy intentions without contraception use, substance abuse history including smoking within the last six months.
What is being tested?
The trial tests a 'device-less' technique for transplanting insulin-producing cells under the skin in patients with Type 1 Diabetes. This method uses a temporary nylon catheter to create a favorable environment for cell survival by promoting new blood vessel growth without triggering adverse body reactions.
What are the potential side effects?
Potential side effects may include local inflammation at the implant site due to foreign body response before it's controlled by the device-less technique and risks associated with any surgical procedure such as infection or bleeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of Adverse Events/Serious Adverse Events
Rate of inflammation in the DL implant site
Secondary study objectives
Probability of rejection or injury analyzed using the Molecular Microscope Diagnostic System (MMDx) system by measuring the expressions of all genes within the graft
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
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).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Type 1 Diabetes include insulin therapy, islet cell transplantation, and continuous subcutaneous insulin infusion (CSII). Insulin therapy involves regular injections or pump delivery of insulin to manage blood glucose levels.
Islet cell transplantation aims to restore insulin production by transplanting insulin-producing cells, but it often requires immunosuppressive drugs and faces challenges like cell loss and foreign body response. The Device-less (DL) Transplant Modality is a novel approach that induces angiogenesis and reduces foreign body response, enhancing the survival of transplanted cells.
This is crucial for T1D patients as it potentially offers a more sustainable and less invasive method to achieve insulin independence and better glycemic control.
Islet cell transplantation in diabetes mellitus--from bench to bedside.Preserving and restoring bone with continuous insulin infusion therapy in a mouse model of type 1 diabetes.Recent advances in pancreatic transplantation.
Islet cell transplantation in diabetes mellitus--from bench to bedside.Preserving and restoring bone with continuous insulin infusion therapy in a mouse model of type 1 diabetes.Recent advances in pancreatic transplantation.
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
942 Previous Clinical Trials
434,404 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
235 Previous Clinical Trials
142,348 Total Patients Enrolled
James Shapiro, MD, PhDPrincipal InvestigatorUniversity of Alberta
8 Previous Clinical Trials
244 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group