Actively Recruiting

Phase Not Applicable
Age: 12Years - 70Years
All Genders
Healthy Volunteers
NCT07479134

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

Age: 12Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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