Diabete Type 2STEM-DMNCT07344324
Study Evaluating the Safety and Feasibility of Endoscopic Duodenal Injections of Autologous Mesenchymal Stem Cells
A study testing endoscopic duodenal injection of ADMSCs in people with Diabete Type 2 and Insulin Resistant Diabetes (Mellitus), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Type 2 Diabetes Mellitus (T2DM) pathogenesis increasingly involves "diabetic duodenopathy," characterized by proximal intestinal immune and epithelial dysregulation. This study investigates the endoscopic delivery of adipose-derived mesenchymal stem cells (ADMSCs) into the duodenum and proximal jejunum as a… Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 2, Insulin Resistant Diabetes (Mellitus), Obesity
- What is being tested?
- endoscopic duodenal injection of ADMSCs
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2026to 30 Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Pilot Study Evaluating the Safety, Feasibility, and Therapeutic Potential of Endoscopic Duodenal Injection of Adipose Tissue-Derived Mesenchymal Stem Cells in Patients With Type 2 Diabetes Mellitus.
Type 2 Diabetes Mellitus (T2DM) pathogenesis increasingly involves "diabetic duodenopathy," characterized by proximal intestinal immune and epithelial dysregulation. This study investigates the endoscopic delivery of adipose-derived mesenchymal stem cells (ADMSCs) into the duodenum and proximal jejunum as a disease-modifying therapy. By leveraging the paracrine immunomodulatory and regenerative effects of ADMSCs in close proximity to the pancreatico-enteroendocrine system, this targeted approach aims to restore insulin sensitivity and $\beta$-cell function while minimizing systemic exposure. The clinical safety and feasibility of this novel delivery route remain to be established.
- Being tested
- endoscopic duodenal injection of ADMSCs
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic duodenal injection of ADMSCsProcedure or surgery
Biopsy Protocol Mucosal biopsies (12 at baseline; 6 at follow-up) will be collected from the Treitz angle to the genu inferius. Samples for ex vivo analysis will be transported at 37°C in sterile medium within 15 minutes.
ADMSC Preparation and Delivery Autologous adipose tissue, harvested via mini-liposuction, will undergo mechanical activation (ELEA Method: 2000 rpm for 8 min). The activated fat is filtered (2 mm), emulsified, and loaded into a 19-gauge needle. Under deep sedation, the substrate will be injected submucosally from the Treitz angle to the superior duodenal genu, ensuring papilla preservation.
| Study group | Role | What they receive |
|---|---|---|
| 15 participants with T2DM | Experimental | Subjects with a BMI between ≥ 25 and ≤ 35 kg/m2, T2DM and age between 30-65 will be considered eligible for the study. Receives: Procedure: endoscopic duodenal injection of ADMSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 5.0
Assessment of the safety and tolerability of the endoscopic duodenal injection of autologous adipose tissue-derived Mesenchymal Stem Cells. Safety will be evaluated by monitoring the frequency and severity of all adverse events and serious adverse events occurring during the study period.
Measured: From the time of the endoscopic procedure through Month 12 post-procedure.
Secondary outcomes (4)
Change From Baseline in Glycated Hemoglobin at Month 12
Mean change from baseline in Glycated Hemoglobin (HbA1c) levels. This physiological parameter is used to evaluate the long-term control of blood sugar levels. The data will be aggregated as the mean change from the start of the study to the final follow-up.
Measured: Baseline (Day 0) and Month 12.
Change From Baseline in Total Daily Insulin Requirement at Month 12
Mean change from baseline in the total daily dose of insulin required by the participant. The dose is measured in International Units per Kilogram per Day. This measure assesses if the treatment reduces the patient's dependence on external insulin.
Measured: Baseline (Day 0) and Month 12.
Change From Baseline in Fasting C-peptide Levels at Month 12
Mean change from baseline in fasting C-peptide levels. This parameter is used as a surrogate marker for endogenous insulin production and pancreatic beta-cell function. It is measured in nanograms per milliliter.
Measured: Baseline (Day 0) and Month 12.
Change From Baseline in Lipid Profile Parameters at Month 12
Mean change from baseline in lipid profile parameters, including Total Cholesterol, Low-Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), and Triglycerides. These physiological parameters are measured in milligrams per deciliter (mg/dL) to evaluate the metabolic impact of the Mesenchymal Stem Cell transplantation. Data will be aggregated as the mean change for each lipid component.
Measured: Baseline (Day 0) and Month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start2 Oct 2026 (estimated)
- Primary completion2 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- IVO BOSKOSKI, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344324
- Sponsor's protocol ID
- 7976
- Acronym
- STEM-DM
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No