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Could your own cells replace insulin shots? early trial aims to find out

NCT ID NCT07118475

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests whether insulin-making cells grown from a patient's own pancreatic tissue can be safely transplanted under the belly skin to reduce or replace insulin shots. Twenty-four adults with insulin-dependent type 2 diabetes will take part. The main goal is safety, but researchers will also check blood sugar control and insulin needs.

What this could mean

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

Active substance
autologous islet cells grown from the patient's own pancreatic tissue
What this could lead to
If successful, this could reduce or eliminate the need for daily insulin injections in some people with type 2 diabetes, offering a functional cure.
What could go wrong
This is a very early, small study (24 people) focused on safety. The cells may not work as hoped, and there are risks from the tissue collection procedure and transplant.

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 24 people

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

Started

Oct 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 75 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.

I. Eligibility Criteria: 1. Age of 18-75 years (inclusive of 18 and 75) on the day of signing the informed consent form, without gender restriction; 2. Type 2 diabetes patients who meet the diagnostic criteria of the "Chinese Diabetes Prevention and Control Guidelines (2024 Edition)"; 3. Dependent on exogenous insulin therapy; 4. Compensatory failure or exhaustion of pancreatic function: ① Fasting serum C-peptide ≤ 1.0 ng/ml in the absence of hypoglycemia (blood glucose \> 3.9 mmol/l); ② The average difference ≤ 1.0 ng/ml in serum C-peptide levels at 2, 4, and 6 minutes after arginine stimulation (intravenous injection of 5g arginine) compared to baseline . 5. Ability to participate in intensive glucose management with good compliance; 6. Mentally stable and able to adhere to the clinical study protocol; 7. Possessing full civil capacity and the ability to independently complete a written informed consent form. II. Exclusion Criteria: 1. Inability to tolerate endoscopic ultrasound-guided pancreatic puncture biopsy due to various reasons; 2. Inability to tolerate subcostal sheath injection due to various reasons; 3. Body mass index (BMI) \> 30 kg/m²; 4. Un-treated proliferative diabetic retinopathy; 5. History of infectious diseases such as hepatitis B, hepatitis C, HIV, and tuberculosis, or presence of active bacterial, fungal, or viral infections (excluding mild localized skin infections); 6. Severe heart disease, meeting any of the following criteria: history of recent myocardial infarction (within the past 6 months), myocardial ischemia identified in myocardial function assessment within the past year, or left ventricular ejection fraction \<30%; 7. Blood pressure: systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg; 8. Liver function indicators: Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) are more than twice the upper limit of normal values; 9. Glomerular filtration rate (GFR) \< 60 ml/min/1.73m²; 10. History of invasive aspergillosis, histoplasmosis, or coccidioidomycosis within the past year; 11. Laboratory findings showing hemoglobin (Hb) below 90 g/L, or lymphopenia (0.5×10⁹/L), neutropenia (\<1.0×10⁹/L), or thrombocytopenia (\<75×10⁹/L); 12. Patients with any coagulation disorder or other disease requiring long-term anticoagulant therapy, or those with an International Normalized Ratio (INR) \> 1.5; 13. Female patients: positive pregnancy test, breastfeeding, or unwilling to use effective contraception during the study; male patients: planning to father a child during the study or unwilling to use effective contraception; 14. History of prior tumor (excluding completely resected squamous cell carcinoma and cutaneous basal cell carcinoma); 15. History of smoking, alcohol abuse, or drug abuse; 16. Severe gastrointestinal dysfunction, gastrointestinal immune diseases, peptic ulcers, and other conditions that may interfere with oral drug absorption; 17. Have severe mental and psychological disorders; 18. Have participated in other clinical trials in the past 3 months; 19. History of receiving attenuated live vaccines within 2 months of registration; 20. Researchers believe that other reasons make the participant unsuitable for this clinical trial.

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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

    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

  • Zhongshan Hospital

    Shanghai, 200032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.