1. 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

2. 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

3. 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

4. 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

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

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

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

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

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

10. 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