Combination treatment of autologous bone marrow stem cell transplantation andhyperbaric oxygen therapy for type 2 diabetes mellitus: A randomized controlledtrial

摘要

The objective of this study was to compare standard treatment versus the combination ofintrapancreatic autologous stem cell (ASC) infusion and hyperbaric oxygen treatment (HBOT)before and after ASC in the metabolic control of patients with type 2 diabetes mellitus(T2DM). This study was a prospective, randomized controlled trial. The combinedintervention consisted of 10 sessions of HBOT before the intrapancreatic infusion of ASCand 10 sessions afterwards. ASCs were infused into the main arterial supply of thepancreas to maximize the presence of the stem cells where the therapeutic effect is mostdesired. A total of 23 patients were included (control group = 10, intervention group =13). Age, gender, diabetes duration, number of medications taken, body weight and height,and insulin requirements were recorded at baseline and every three months. Also, body massindex, fasting plasma glucose, C-peptide, and HbA1c, C-peptide/glucose ratio (CPGR) weremeasured every three months for one year. HbA1c was significantly lower in theintervention group compared with control throughout follow-up. Overall, 77% of patients inthe intervention group and 30% of patients in the control group demonstrated a decrease ofHbA1c at 180 days (compared with baseline) of at least 1 unit. Glucose levels weresignificantly lower in the intervention group at all timepoints during follow-up.C-peptide levels were significantly higher in the intervention group during follow-up andat one year: 1.9 ± 1.0 ng/mL versus 0.7 ± 0.4 ng/mL in intervention versus control groups,respectively, = 0.0021. CPGR was higher in the intervention group atall controls during follow-up. The requirement for insulin was significantly lower in theintervention group at 90, 180, 270, and 365 days. Combined therapy of intrapancreatic ASCinfusion and HBOT showed increased metabolic control and reduced insulin requirements inpatients with T2DM compared with standard treatment.