Increase in the Expression of Glucose Transporter 2 (GLUT2) on the Peripheral Blood Insulin-Producing Cells (PB-IPC) in Type 1 Diabetic Patients after Receiving Stem Cell Educator Therapy.

Multicenter international clinical trials demonstrated the clinical safety and efficacy by using stem cell educator therapy to treat type 1 diabetes (T1D) and other autoimmune diseases. Previous studies characterized the peripheral blood insulin-producing cells (PB-IPC) from healthy donors with high potential to give rise to insulin-producing cells. PB-IPC displayed the molecular marker glucose transporter 2 (GLUT2), contributing to the glucose transport and sensing. To improve the clinical efficacy of stem cell educator therapy in the restoration of islet ß-cell function, we explored the GLUT2 expression on PB-IPC in recent onset and longstanding T1D patients. In the Food and Drug Administration (FDA)-approved phase 2 clinical studies, patients received one treatment with the stem cell educator therapy. Peripheral blood mononuclear cells (PBMC) were isolated for flow cytometry analysis of PB-IPC and other immune markers before and after the treatment with stem cell educator therapy. Flow cytometry revealed that both recent onset and longstanding T1D patients displayed very low levels of GLUT2 on PB-IPC. After the treatment with stem cell educator therapy, the percentages of GLUT2+CD45RO+ PB-IPC were markedly increased in these T1D subjects. Notably, we found that T1D patients shared common clinical features with patients with other autoimmune and inflammation-associated diseases, such as displaying low or no expression of GLUT2 on PB-IPC at baseline and exhibiting a high profile of the inflammatory cytokine interleukin (IL)-1ß. Flow cytometry demonstrated that their GLUT2 expressions on PB-IPC were also markedly upregulated, and the levels of IL-1ß-positive cells were significantly downregulated after the treatment with stem cell educator therapy. Stem cell educator therapy could upregulate the GLUT2 expression on PB-IPC and restore their function in T1D patients, leading to the improvement of clinical outcomes. The clinical data advances current understanding about the molecular mechanisms underlying the stem cell educator therapy, which can be expanded to treat patients with other autoimmune and inflammation-associated diseases.

Designing an integrated extracorporeal therapy service quality system.

Reorganization in clinical operations of a national service provider organization, Fresenius Medical Care Extracorporeal Alliance (FMC-EA), provided the opportunity to overhaul and integrate quality systems. Under the new structure, the management of acute dialysis, apheresis, open-heart perfusion, and intraoperative autotransfusion services were combined into an integrated service portfolio supported by a multidisciplinary team of nurses, perfusionists, and technicians. This communication is intended to be a concise review of the literature that establishes the foundation for the new quality system as well as a discussion of the five clinical policies and clinical procedure guidelines that govern clinical behavior in mobile, point of care, acute extracorporeal therapy services. The clinical policy standards are based on recognized essentials and guidelines published by professional organizations, federal and state government agencies, and accreditation groups. The standards list the essential behaviors that clinicians should exhibit during the provision of extracorporeal therapy procedures such as acute therapeutic apheresis. Compliance with the redesigned procedure guidelines and policies will provide the clinical practice platform for continuous quality improvement (CQI) activities, benchmarking, and self-improvement. These practices can lead to improvements in the quality of care, a decrease in medical errors, and a reduction in overall health care costs.