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Could Lab-Grown cells free diabetics from insulin shots?

NCT ID NCT07503028

Disease control Sponsor: Celregen Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This early study tests lab-grown pancreatic islet cells (CRG-002) in 10 adults with type 1 or pancreatogenic diabetes who have severe low blood sugar episodes. The cells are infused into the liver or placed under the belly skin. The goal is to see if they are safe and can help the body make insulin, possibly reducing the need for injections.

What this could mean

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

Active substance
lab-grown pancreatic islet cells (CRG-002)
What this could lead to
If it works, this could point toward a way to reduce or stop insulin injections for some people with type 1 diabetes.
What could go wrong
This is a very early, small trial (10 people) focused on safety. The cells may not work well, could be rejected, or might require lifelong immune-suppressing drugs.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 10 people

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

Started

Oct 2025

Expected to finish

Jan 2028

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 70 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: 1. Age 18-70 years, any gender. 2. Long-standing type 1 diabetes or pancreatic diabetes. 3. Significant pancreatic islet dysfunction. 4. Hemoglobin A1c within clinically acceptable range. 5. At least 1 hypoglycemic event requiring external intervention within 12 months. 6. Able to comply with intensive glucose management. 7. Agree to use the study-designated monitoring device. 8. Psychologically stable. 9. Full legal capacity. Exclusion Criteria: 1. Type 2 diabetes. 2. Body mass index (BMI) \> 30 kg/m². 3. Uncontrolled diabetic retinopathy or severe diabetic foot complications. 4. Active infection or positive serology for relevant pathogens. 5. Severe cardiovascular disease. 6. Uncontrolled hypertension. 7. Hematologic disorders affecting HbA1c accuracy. 8. Abnormal liver function. 9. Prior islet transplantation. 10. Renal impairment or insufficient post-transplant recovery. 11. Significant renal impairment. 12. Recent invasive fungal infection. 13. Severe hematologic abnormalities. 14. Coagulopathy. 15. Inadequate contraceptive compliance. 16. Active malignancy. 17. History of substance abuse. 18. Severe gastrointestinal/malabsorption disorders. 19. Severe psychiatric disorder. 20. Participation in other clinical trials within 6 months. 21. Live-attenuated vaccine received within 2 months prior to enrollment. 22. Inability to undergo standard imaging. 23. Other factors deemed unsuitable by investigator.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

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

Pancreatogenic diabetes mellitus T1DM - type 1 diabetes mellitus

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • The First Affiliated Hospital of Anhui Medicaluniversity

    Hefei, Anhui, 230022, China

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