Umbilical Cord Mesenchymal Stromal Cell With Autologous Bone Marrow Cell Transplantation in Established Type 1 Diabetes: A Pilot Randomized Controlled.

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Umbilical Cord Mesenchymal Stromal Cell With Autologous Bone Marrow Cell Transplantation in Established Type 1 Diabetes: A Pilot Randomized Controlled Open-Label Clinical Study to Assess Safety and Impact on Insulin Secretion Featured Article: Jinquan Cai, Zhixian Wu, Xiumin Xu, Lianming Liao, Jin Chen, Lianghu Huang, Weizhen Wu, Fang Luo, Chenguang Wu, Alberto Pugliese, Antonello Pileggi, Camillo Ricordi, and Jianming Tan Diabetes Care Volume 39: 149–157 January 2016

STUDY OBJECTIVE To determine the safety and effects on insulin secretion of umbilical cord (UC) mesenchymal stromal cells (MSCs) plus autologous bone marrow mononuclear cell (aBM-MNC) stem cell transplantation (SCT) without immunotherapy in type 1 diabetes (T1D) Cai J et al. Diabetes Care 2016;39:149–157

STUDY DESIGN AND METHODS 42 patients with T1D were randomized to either SCT or standard care Patients were followed for 1 year at 3-month intervals Primary end point was C-peptide area under the curve (AUCC-Pep) during an oral glucose tolerance test at 1 year Additional end points were safety and tolerability of the procedure, metabolic control, and quality of life Cai J et al. Diabetes Care 2016;39:149–157

RESULTS Treatment was well tolerated At 1 year, metabolic measures improved in treated patients: • AUCC-Pep increased 105.7% in 20 of 21 responders and decreased 7.7% in control subjects • Insulin area under the curve increased 49.3% in the treated group and decreased 5.7% in control subjects • HbA1c decreased 12.6% in the treated group and increased 1.2% in the control group • Fasting glycemia decreased 24.4% in the treated group and 4.3% in control subjects • Daily insulin requirements decreased 29.2% in only the treated group, with no change in control subjects Cai J et al. Diabetes Care 2016;39:149–157

Cai J et al. Diabetes Care 2016;39:149–157

Cai J et al. Diabetes Care 2016;39:149–157

Cai J et al. Diabetes Care 2016;39:149–157

Cai J et al. Diabetes Care 2016;39:149–157

Cai J et al. Diabetes Care 2016;39:149–157

CONCLUSIONS CONCLUSIONS Transplantation of UC-MSC and a BM-MNC was safe and associated with moderate improvement of metabolic measures in patients with T1D Cai J et al. Diabetes Care 2016;39:149–157