Actively Recruiting
Production of Stem Cells for the Generation of Pancreatic Cells
Led by Ospedale San Raffaele · Updated on 2026-03-18
100
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Production of Stem Cells for the Generation of Pancreatic Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 70 years
- Ability and willingness to provide informed consent (or assent with parental consent for minors)
- Diagnosed with pancreatic beta cell dysfunction including type 1 diabetes, type 2 diabetes, MODY, Wolfram syndrome, or pancreatogenic diabetes
- Healthy control donors without pancreatic beta cell dysfunction
- Pregnant or breastfeeding women may participate if they meet other criteria
You will not qualify if you...
- Age below 12 or above 70 years
- Health condition too poor for safe tissue collection (e.g., acute low or high blood sugar at sampling)
- Unable or unwilling to provide informed consent or assent
- Active cancer or current cancer treatment
- Known infection with HIV, Hepatitis B, or Hepatitis C
- Use of medications interfering with iPSC generation unless approved by investigators
- For skin biopsy participants: bleeding disorders, local skin infection, allergy to anesthetics, or use of anticoagulants
AI-Screening
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Trial Site Locations
Total: 1 location
1
Diabetes Research Institute
Milan, Italy, 20132
Actively Recruiting
Research Team
V
Valeria Sordi, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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