The Core’s Activities | The Cell Manufacturing Core

The Schulze Diabetes Institute (SDI) at the University of Minnesota runs a fully GMP-compliant Cell Therapy Manufacturing & Research & Development facility devoted to producing:

clinical-grade allogeneic islet cell preparations for Type 1 diabetes transplantation.
clinical-grade autologous islet cell preparations for the treatment of chronic pancreatitis in support of M Health Fairview’s Total Pancreatectomy & Islet Auto Transplant (TP-IAT Program).

Under the leadership of Bernhard Hering, MD, and management of Muhamad Abdulla, BSc, the unit handles everything from donor-pancreas procurement through final product release testing, ensuring each islet batch meets strict criteria for viability, purity and potency before patient infusion.

The Core’s process has underpinned phase 3 trials showing that transplanted islets can restore near-normal glycemia, stabilize blood sugar swings and prevent severe hypoglycemia with an acceptable safety profile in high-risk patients.

M Health Fairview’s Total Pancreatectomy with Islet Auto-Transplant (TP-IAT) program was the first of its kind in 1977 and has since grown into the world’s largest, performing over 800 procedures to date. It’s one of only 60 centers nationwide designated a National Pancreas Foundation Center of Excellence, reflecting unmatched surgical experience and multidisciplinary support.