Production of Stem Cells for the Generation of Pancreatic Cells

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

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.

Conditions1

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