Production of Stem Cells for the Generation of Pancreatic Cells

NCT07479134 | Recruiting

• 1 other identifier: iBETA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes

Keywords

diabetes; stem cells, induced pluripotent stem cells

Outcome Measures

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.

  within 7-60 days after culture establishment

Study Arms (1)

Biospecimen Collection for iPSC Generation and β Cell Differentiation

EXPERIMENTAL

All participants will provide a single biological sample (skin biopsy, blood draw, or urine collection) for isolation of somatic cells. These cells will be reprogrammed into induced pluripotent stem cells (iPSCs) and differentiated into insulin-producing β cells to study pancreatic function and disease mechanisms. No therapeutic intervention is administered.

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

Interventions

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

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.

Biospecimen Collection for iPSC Generation and β Cell Differentiation

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 12 and 70 years.
• Ability and willingness to provide informed consent (or assent with parental consent for minors).
• Group 1: Individuals diagnosed with pancreatic β cell dysfunction, including but not limited to:
• Type 1 Diabetes
• Type 2 Diabetes
• Maturity Onset Diabetes of the Young (MODY)
• Wolfram Syndrome
• Pancreatogenic Diabetes
• Group 2: Healthy control donors without pancreatic β cell dysfunction.

You may not qualify if:

• Age below 12 or above 70 years.
• Health condition too compromised to allow safe tissue collection (e.g., acute hypoglycemia \<70 mg/dL or hyperglycemia \>140 mg/dL at sampling).
• Inability or unwillingness to provide informed consent/assent.
• Active malignancy or current cancer treatment.
• Known infection with HIV, Hepatitis B, or Hepatitis C.
• Use of medications that may interfere with iPSC generation (e.g., high-dose corticosteroids, immunomodulators), unless approved by investigators.
• For participants undergoing skin biopsy: bleeding disorders, local skin infection, allergy to anesthetics, or use of anticoagulants.

Sponsors & Collaborators

• Ospedale San Raffaele: lead

Study Sites (1)

Diabetes Research Institute

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Blood Specimen Collection; Urine Specimen Collection

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Valeria Sordi, PhD

CONTACT

+390226432643; sordi.valeria@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Endocrinology Director, Diabetes Research Institute, Director, Regenerative Medicine and Transplant Unit

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 28, 2035
• Study Completion (Estimated): February 28, 2036
• Last Updated: March 18, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)