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RECRUITING
NCT07479134
NA

Production of Stem Cells for the Generation of Pancreatic Cells

Sponsor: Ospedale San Raffaele

View on ClinicalTrials.gov

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.

Official title: Production Of Induced Pluripotent Stem Cells (iPSCs) For The Generation Of Insulin-Producing β Cells

Key Details

Gender

All

Age Range

12 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-03-01

Completion Date

2036-02-28

Last Updated

2026-03-18

Healthy Volunteers

Yes

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.

Locations (1)

Diabetes Research Institute

Milan, Italy