Transplantation of Encapsulated Pancreatic Islets as a Treatment for Patients with Type 1 Diabetes Mellitus

Table 2

Product-Release Test for islets before transplantation.

Test	Test method	Criteria
Purity	DTZ staining is used for islet identity, which is visualized by qualified personnel	≥30%
Viability	Fluorescent dye (FDA and PI) staining is used for islet viability, which is determined by qualified personnel	≥70%
Islet yield	DTZ staining is used for islet identity and islet number is counted by qualified personnel	First transplant: ≥5,000 IEQ/kg RBW; Second transplant: ≥10,000 IEQ/kg RBW
Transplant tissue volume	Centrifuge and measure packed cell volume in conical tube	≤10 mL
Microbiological test	Gram stain on 100 𝜇L smear with microscopic examination by qualified personnel	No intact organism observed
Endotoxin content	QCL-1000 Chromogenic LAL Test Kit, Cat number 50-647U, (BioWhittaker, Inc.)	≤5 EU/kg body weight of the potential recipient
Glucose static incubation	In vitro insulin release in 1.6 mM and 16.7 mM glucose. Expressed by SI	≥1.5

DTZ: dithizone.
FDA: fluorescein diacetate, for live cells.
PI: propidium iodide, for dead cells.
RBW: recipient body weight.
SI: stimulation index.