Could a cell injection free type 1 diabetics from insulin?
NCT ID NCT06731218
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
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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.
- Started
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Feb 2025
- Expected to finish
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Dec 2031
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 60 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.
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.
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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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Tianjin First Center Hospital
RECRUITINGTianjin, Tianjin Municipality, 300000, China
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