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Could a cell injection free type 1 diabetics from insulin?

NCT ID NCT06731218

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-stage trial tests a new treatment called RGB-5088 for people with type 1 diabetes. It involves transplanting insulin-making cells under a muscle layer in the abdomen. The goal is to see if it is safe and if it can help patients control blood sugar without insulin shots. Only 10 people will take part in this first study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RGB-5088 islet cells
What this could lead to
If successful, this could point toward a way to reduce or eliminate insulin injections for people with type 1 diabetes.
What could go wrong
This is a very early Phase 1 trial with only 10 people. It is designed mainly to check safety, not yet to prove it works. Risks include side effects from the procedure or the cells not lasting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Age: 18-60 years old (including 18 and 60 years old), male and female; * Type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney); * Stimulated C-peptide \< 0.3 ng/mL; * The patient had at least one severe hypoglycemia within 12 months before being included in the project Key Exclusion Criteria: * Type 2 diabetes patients; * Untreated proliferative diabetes retinopathy; * Serious heart disease; * Serious gastrointestinal dysfunction ; * Serious psychological diseases; * Any history of malignancy; * Have a history of tobacco, alcohol and drug abuse; * For female subjects: pregnancy test positive, lactation or unwilling to use effective contraceptive measures during the study period, male patients: intent to procreate or unwilling to use effective contraceptive measures during the study period.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tianjin First Center Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300000, China

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