NCT07479134 Production of Stem Cells for the Generation of Pancreatic Cells
| NCT ID | NCT07479134 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ospedale San Raffaele |
| Condition | Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2035-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-03-01 with a primary completion date of 2035-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this interventional study is to generate induced pluripotent stem cells (iPSCs) from somatic cells and differentiate them into insulin-producing β cells in patients with metabolic and genetic pancreatic diseases and in healthy controls. The main questions it aims to answer are: Can somatic cells from healthy individuals and patients with diabetes be successfully reprogrammed into iPSCs? Can these iPSCs be differentiated into functional insulin-producing β cells suitable for studying disease mechanisms and developing cell-based therapies? Participants will provide a single biological sample (either a 3 mm skin punch biopsy, a blood sample, or a urine sample) collected under sterile conditions. The samples will be used to derive somatic cells, which will then be reprogrammed into iPSCs and differentiated into β cells for laboratory analyses. Participants will: Undergo a one-time sample collection (skin biopsy, blood draw, or urine collection) at Ospedale San Raffaele Receive standard post-procedure care (if applicable) This research aims to improve understanding of β cell function and dysfunction in diabetes and to advance personalized regenerative therapies for β cell replacement.
Eligibility Criteria
Inclusion Criteria: Age between 12 and 70 years. Ability and willingness to provide informed consent (or assent with parental consent for minors). Group 1: Individuals diagnosed with pancreatic β cell dysfunction, including but not limited to: Type 1 Diabetes Type 2 Diabetes Maturity Onset Diabetes of the Young (MODY) Wolfram Syndrome Pancreatogenic Diabetes Group 2: Healthy control donors without pancreatic β cell dysfunction. Pregnant or breastfeeding women may be included if they meet the inclusion criteria. Exclusion Criteria: Age below 12 or above 70 years. Health condition too compromised to allow safe tissue collection (e.g., acute hypoglycemia \<70 mg/dL or hyperglycemia \>140 mg/dL at sampling). Inability or unwillingness to provide informed consent/assent. Active malignancy or current cancer treatment. Known infection with HIV, Hepatitis B, or Hepatitis C. Use of medications that may interfere with iPSC generation (e.g., high-dose corticosteroids, immunomodulators), unless approved by investigators. For participants undergoing skin biopsy: bleeding disorders, local skin infection, allergy to anesthetics, or use of anticoagulants.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07479134 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 70 Years, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07479134 currently recruiting?
Yes, NCT07479134 is actively recruiting participants. Contact the research team at sordi.valeria@hsr.it for enrollment information.
Where is the NCT07479134 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07479134 clinical trial?
NCT07479134 is sponsored by Ospedale San Raffaele. The trial plans to enroll 100 participants.
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