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Gut stem cell shot aims to reverse diabetes

NCT ID NCT07344324

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This early study tests if injecting a person's own stem cells into the upper gut is safe and feasible for treating type 2 diabetes. The stem cells are taken from belly fat and processed before being injected during a scope procedure. Only 15 people will take part, and the main goal is to check for side effects, not to prove it works.

What this could mean

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

Active substance
adipose-derived mesenchymal stem cells (ADMSCs)
What this could lead to
If it works, this could point toward a new way to improve insulin sensitivity and blood sugar control in type 2 diabetes, potentially reducing the need for medication.
What could go wrong
This is a very early, small pilot study (15 people) focused on safety, not effectiveness. The procedure is invasive and may cause side effects. Success is far from guaranteed.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 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

25 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * • Adults aged between 25-70 years * Diagnosis of T2DM from at least 1 years * HbA1c between 7.5% and 10% * BMI between 25 and 35 kg/m² * Fasting C-peptide ≥1 ng/ml * Stable antidiabetic regimen for ≥3 months (including insulin s.c.) * Insulin resistance (HOMA-IR \> 5) * Healthy volunteers: BMI \< 25, age between 18-75 and no diagnosis of T2DM or insulin resistance (HOMA-IR\<2.5), with no significant acute or chronic medical conditions and not taking medications that could interfere with the esophagogastroduodenoscopy + biopsies Exclusion Criteria: * Type 1 DM or secondary diabetes * Celiac disease * History of pancreatitis or GI surgery * Active infection or malignancies ongoing * Active gastro-duodenal ulcers * Duodenum not accessible endoscopically for previous surgery or other conditions * History of autoimmune disease * Active malignancy or recent cancer treatment * Use of certain medications (e.g., immunosuppressants, systemic corticosteroids) * Active Smoking (\>5 sigarettes/die) * Anticoagulant treatment not suspendable * Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification. * Drug or alcohol abuse * Continuous glucocorticoid or anti-inflammatory treatment * Uncontrolled thyroid disease. * Pregnancy, breastfeeding * Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study. * Liver cirrhosis of any Child-Phugh stage or MELD\> 15 * Chronic Severe Renal Insufficiency (eGFR \< 30 ml/min/1.73 m2 based on CKD-EPI equation) * Currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered * Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.

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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 official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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