What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes include insulin therapy, islet transplantation, and continuous subcutaneous insulin infusion (CSII). Insulin therapy can cause hypoglycemia, weight gain, and injection site reactions. Islet transplantation, similar to the DL Transplant Modality, can lead to risks such as cell loss, immune rejection, and the need for immunosuppressive drugs, which carry their own side effects like increased infection risk and organ toxicity. CSII can cause skin infections and require frequent monitoring to avoid complications. The DL Transplant Modality aims to reduce foreign body response and improve cell survival, potentially mitigating some of these risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 1 Diabetes, primarily focusing on insulin therapy and continuous glucose monitoring systems. While pancreatic transplantation and islet cell implantation are advanced therapies that have shown promise, they are not yet widely approved or used due to limitations such as donor scarcity and procedural risks. The Device-less (DL) Transplant Modality, which aims to induce angiogenesis and reduce foreign body response to support the survival of insulin-producing cells, represents a novel approach currently under investigation and has not yet received FDA approval.

What other types of research exist?

Promising, novel alternatives to the Device-less (DL) Transplant Modality for Type 1 Diabetes patients include: 1) Stem cell therapy, which involves differentiating stem cells into insulin-producing cells and potentially using less aggressive, nonmyeloablative preparative regimens to reduce complications. 2) Encapsulation techniques that protect transplanted islets from immune attack while allowing insulin release. 3) Advanced biomaterials that minimize foreign body response and support the survival and function of transplanted cells. These approaches aim to improve the efficacy and safety of islet transplantation and other cell-based therapies for T1D.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

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).

Do I qualify?Apply below to find out

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.