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