Can transplanted cells restore insulin production in type 2 diabetes?
NCT ID NCT07794254
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Peking University People's Hospital
Beijing, Beijing Municipality, China
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