Active not recruitingPHASE1INTERVENTIONAL

Safety of ENC-201-CED ENCRT

This research study is for people with Type 1 diabetes and is investigating a new treatment called ENC-201-CED. The main goal is to check how safe this new treatment is and if people can comfortably tolerate it when it's placed just under the skin. This is the first stage of testing this new treatment in humans, and it's called a 'Phase 1' study. We are not yet looking at how well it treats diabetes, but rather focusing on its safety. By understanding the safety first, we can decide if it's suitable to study further in the future. We hope this research could lead to new ways to manage Type 1 diabetes.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Encellin

Enrolment target

Start

01 May 2024

Estimated completion

30 Oct 2026

Diabetes Mellitus, Type 1

What is this study about?

Imagine your body needs a special messenger called insulin to turn sugar from food into energy. In Type 1 diabetes, your body doesn't make enough of this messenger. This study is testing something new called ENC-201-CED, which involves placing special cells (called hPI) just under your skin. These cells are designed to help with diabetes.

This is a very early study, known as Phase 1. When a new medicine or treatment is developed, it goes through different phases. Phase 1 is like the first step with human volunteers after lab tests. The main aim here isn't to see how well it treats your diabetes directly, but rather to carefully check if it's safe for people and if your body can tolerate having it. Think of it like taking a new car for a basic safety check before driving it on a long journey.

The information we gather from this study will be really important. It will help doctors and researchers understand if ENC-201-CED could be a safe option to test further in larger studies, potentially leading to new ways to help people living with Type 1 diabetes in the future.

Key takeaways

This study is testing a new treatment (ENC-201-CED) for Type 1 diabetes.
It's a 'Phase 1' study, meaning the main focus is on safety and how well people tolerate the treatment.
The treatment involves placing special cells under the skin.
Adults with Type 1 diabetes, aged 18-70, can be considered.
Participation involves clinic visits for monitoring your health after receiving the treatment.
This research hopes to find new ways to manage Type 1 diabetes in the future.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old, diagnosed with Type 1 diabetes. Both men and women can take part.

There are also specific medical checks that your local study doctor will perform. You'll need to meet the same health requirements as someone who would normally receive a standard 'islet cell infusion', which is a treatment sometimes used for Type 1 diabetes. If you've been told you're not suitable for a standard islet cell infusion, you likely won't be able to join this study either.

Your study doctor will carefully review your full medical history and perform tests to make sure that taking part in this research is safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Do you have Type 1 diabetes?
Are you generally suitable for a standard 'islet cell infusion' treatment (your doctor can explain this)?
Are you able to attend regular clinic visits for monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study team will first thoroughly check if you're suitable. If you are, you'll receive the ENC-201-CED treatment, which will be placed under your skin. After this, you'll have several visits to the clinic for check-ups. These visits will involve blood tests, physical examinations, and questions about how you're feeling and your diabetes management. The main goal is to monitor your health and how your body reacts to the treatment over time. The exact number of visits and the total length of time you'll be involved will be explained in detail by the study team before you agree to join.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study is that you would be among the first to receive a new investigational treatment for Type 1 diabetes, potentially contributing to future advancements. However, as this is an early-stage study, the main aim is safety, and there's no guarantee it will improve your diabetes. Potential risks are not fully known, but could include discomfort or reactions at the site where the treatment is placed, or other side effects. The research team will discuss all known potential risks with you in detail. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

UHN
Verified postcode
Toronto, Canada
McGill University Health Centre
Verified postcode
Montreal, Canada

Common questions

What is ENC-201-CED?

It's a new treatment being tested for Type 1 diabetes, involving special cells placed under the skin.

What is a 'Phase 1' study?

It's the first stage of testing a new treatment in people, mainly to check if it's safe and tolerable.

Will this treatment cure my diabetes?

The main goal of this early study is to check safety, not to cure diabetes. It's too soon to tell if it will improve your condition.

How is the treatment given?

It's placed just under the skin, in a method similar to some other medical procedures.

Can women take part?

Yes, both men and women between 18 and 70 years old can be considered for this study.