Gut stem cell shot aims to reverse diabetes
NCT ID NCT07344324
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
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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
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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25 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * • 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
Only the study team decides who joins. These are the ways to reach them.
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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.
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