NCT07344324Not yet recruiting
Study Evaluating the Safety and Feasibility of Endoscopic Duodenal Injections of Autologous Mesenchymal Stem Cells
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.
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 22 Dec 2025
- Start date
- 2 Oct 2026
- Primary completion date
- 2 Oct 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07344324
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 2 Oct 2026 to the primary completion date, 2 Oct 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Duodenum not accessible endoscopically for previous surgery or other conditions
- Use of certain medications (e.g., immunosuppressants, systemic corticosteroids)
- Drug or alcohol abuse
- 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
Other illness
- Type 1 DM or secondary diabetes
- Celiac disease
- History of pancreatitis or GI surgery
- Active infection or malignancies ongoing
- History of autoimmune disease
- Active malignancy or recent cancer treatment
- Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification.
- Uncontrolled thyroid disease.
- Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study.
Lab values
- Chronic Severe Renal Insufficiency (eGFR \< 30 ml/min/1.73 m2 based on CKD-EPI equation)
Other
- Active gastro-duodenal ulcers
- Active Smoking (\>5 sigarettes/die)
- Anticoagulant treatment not suspendable
- Continuous glucocorticoid or anti-inflammatory treatment
- Pregnancy, breastfeeding
- Liver cirrhosis of any Child-Phugh stage or MELD\> 15
- Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.
Who the study is looking for
- • 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
Age in the registry: 25 years to 70 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.