Production of Stem Cells for the Generation of Pancreatic Cells
ConditionDiabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-70
SponsorOspedale San Raffaele
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Biological - skin biopsy, blood draw, or urine collection for iPSC generation
Procedure/SurgeryThis 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Biospecimen Collection for iPSC Generation and β Cell DifferentiationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
generation of iPSC
Successful generation of iPSCs from somatic cells, defined by \>80% expression of pluripotency markers (SSEA4, OCT4, NANOG) within 7-60 days after culture establishment.
Time frame
within 7-60 days after culture establishmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov