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Production of Stem Cells for the Generation of Pancreatic Cells

NCT07479134 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Biological - skin biopsy, blood draw, or urine collection for iPSC generation

This study involves a single, minimally invasive biological sampling to obtain somatic cells for the generation of induced pluripotent stem cells (iPSCs). Each participant will undergo only one procedure: a 3 mm skin punch biopsy under local anesthesia, a peripheral blood draw (up to 20 mL), or a urine collection (up to 300 mL), depending on laboratory needs. Samples will be processed to isolate fibroblasts, blood cells, or urine-derived epithelial cells, which will be reprogrammed into iPSCs using a non-integrating RNA-based system . The resulting iPSCs will be characterized for pluripotency and differentiated into insulin-producing β cells.

Sponsors & Collaborators

  • Ospedale San Raffaele

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2035-02-28
Completion
2036-02-28

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07479134 on ClinicalTrials.gov