Can transplanted cells restore insulin production in type 2 diabetes?

NCT ID NCT07794254

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This phase 1 trial tests whether injecting RGB-5088 islet cells under the abdominal muscle can safely help people with type 2 diabetes. The study enrolls 10 adults aged 18 to 65 who have had diabetes for at least 5 years and currently use insulin. Researchers will monitor safety and check whether the cells improve blood sugar control, aiming for an HbA1c below 7% or a meaningful reduction. The ultimate goal is to see if this approach can reduce or eliminate the need for insulin injections.

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 cell injection, transplanted under the abdominal muscle
What this could lead to
If successful, this could lead to a way to restore natural insulin production, potentially reducing or eliminating the need for insulin injections in some people with type 2 diabetes.
What could go wrong
This is an early, small trial with only 10 participants, so results may not apply broadly. Risks include surgical complications, immune rejection, and the possibility that the cells may not work as hoped.

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.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2032

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 65 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.

Inclusion Criteria: * Age 18-65 years (inclusive), male or female. * Diagnosis of type 2 diabetes mellitus (T2DM) with a disease duration ≥5 years. * Body mass index (BMI) 18-30 kg/m². * Glycated hemoglobin (HbA1c) 7.0%-10.0%. * Adherence to guideline-recommended diet and exercise control; willing and able to comply with lifestyle interventions throughout the study. * On insulin therapy following adequate trials of standard and advanced glucose-lowering regimens as per guidelines. * Subjects are dependent on insulin therapy. * Women of childbearing potential, or male participants whose partners are of childbearing potential, must agree to use highly effective contraception throughout the study and for at least 6 months post-treatment. * Able to understand the study protocol, willing to participate voluntarily, and provide signed written informed consent. Exclusion Criteria: * Diagnosis of any form of diabetes other than T2DM. * Daily insulin dose \>1.5 U/kg or total daily dose \<20 U. * Fasting plasma glucose ≥15.0 mmol/L. * Positive for any diabetes-related autoantibodies at screening (prior to adipose tissue collection). * Proliferative diabetic retinopathy requiring treatment or unstable. * Active infection; hepatitis B, hepatitis C, syphilis, HIV antibody positivity; or history of tuberculosis. * History of major cardiovascular or cerebrovascular disease. * Uncontrolled hypertension despite pharmacological therapy. * Clinically significant abnormal liver function tests. * Clinically significant abnormal renal function tests. * Clinically significant abnormalities in hematology parameters. * Positive pregnancy test; breastfeeding. * History of malignant tumor, except for malignancies with an excellent expected prognosis after curative treatment. * History of tobacco dependence, alcohol abuse, substance abuse, or illicit drug use. * Use of concomitant medications (other than current antidiabetic agents) that, in the Investigator's opinion, may interfere with glycemic control. * Any active autoimmune disease or history of autoimmune disease deemed by the Investigator to be incompatible with study participation. * Documented history of a psychiatric disorder. * History of hemoglobinopathy, other significant hematological disorders, or any condition causing hemolysis or erythrocyte instability. * Participation in another interventional clinical trial within 3 months prior to signing the Informed Consent Form. * Prior islet cell infusion/transplantation. * Receipt of any other stem cell therapy. * Judged by the Investigator to have poor compliance or unwillingness to adhere to study procedures.

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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

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  1. The places running it

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

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Peking University People's Hospital

    Beijing, Beijing Municipality, China

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