Combination treatment of autologous bone marrow stem cell transplantation and hyperbaric oxygen therapy for type 2 diabetes mellitus: A randomized controlled trial

Abstract

The objective of this study was to compare standard treatment versus the combination of intrapancreatic 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 combined intervention consisted of 10 sessions of HBOT before the intrapancreatic infusion of ASC and 10 sessions afterwards. ASCs were infused into the main arterial supply of the pancreas to maximize the presence of the stem cells where the therapeutic effect is most desired. 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 mass index, fasting plasma glucose, C-peptide, and HbA1c, C-peptide/glucose ratio (CPGR) were measured every three months for one year. HbA1c was significantly lower in the intervention group compared with control throughout follow-up. Overall, 77% of patients in the intervention group and 30% of patients in the control group demonstrated a decrease of HbA1c at 180 days (compared with baseline) of at least 1 unit. Glucose levels were significantly lower in the intervention group at all timepoints during follow-up. C-peptide levels were significantly higher in the intervention group during follow-up and at one year: 1.9 ± 1.0 ng/mL versus 0.7 ± 0.4 ng/mL in intervention versus control groups, respectively, p = 0.0021. CPGR was higher in the intervention group at all controls during follow-up. The requirement for insulin was significantly lower in the intervention group at 90, 180, 270, and 365 days. Combined therapy of intrapancreatic ASC infusion and HBOT showed increased metabolic control and reduced insulin requirements in patients with T2DM compared with standard treatment.

Hyperbaric oxygen therapy for healthy aging: From mechanisms to therapeutics

“…While the above two mechanisms potentially ensure the efficacy of HBOT alone by stimulating inherent stem cells, the third mechanism we summarize here is that combining HBOT with stem cell transplantation can enhance the therapeutic value of stem cells. Compared with monotherapy, a combined treatment of stem cell transplantation and HBOT has shown better therapeutic effects on cardiac regeneration [ 123 ], neurological function recovery [ 124 ], and metabolic control [ 125 ]. Considering the great promise of stem cell transplantation in aging or geriatric medicine, it is speculated that HBOT can be used as an adjunct therapy to improve survival and function of the transplanted stem cells.…”

Transplantation of insulin‐producing cells derived from human MSCs to treat diabetes in a non‐human primate model

“…11,12 It is difficult for intravenously injected MSCs to enter the pancreas, 13 and most reports of successful injection of MSCs into the pancreas resulted from injection in the dorsal pancreatic artery, in which the resulting decreased insulin consumption can last for more than 1 year. 14,15 The limited clinical efficacy and the unpredictable nature of MSC differentiation have severely limited the development of MSC transplantation as a therapeutic strategy to manage type 1 and type 2 diabetes. Currently, radical therapy for end-stage diabetes involves intraportal allograft islet transplantation with the use of immunosuppressive agents, and the 5-year insulin-independent rate exceeds 50% (called the Edmonton Protocol).…”

“…Stem cell regeneration is a potential insulin replacement therapy for type 1 and 2 diabetes 11,12 . It is difficult for intravenously injected MSCs to enter the pancreas, 13 and most reports of successful injection of MSCs into the pancreas resulted from injection in the dorsal pancreatic artery, in which the resulting decreased insulin consumption can last for more than 1 year 14,15 . The limited clinical efficacy and the unpredictable nature of MSC differentiation have severely limited the development of MSC transplantation as a therapeutic strategy to manage type 1 and type 2 diabetes.…”

Mesenchymal Stromal Cell-Mediated Immune Regulation: A Promising Remedy in the Therapy of Type 2 Diabetes Mellitus

“…21 Besides, some studies have investigated the therapeutic effects of bone marrow-derived mononuclear cells (BMMNCs) or bone marrow-derived stem cells (BM-SCs) on T2DM. [152][153][154][155][156][157] Notably, the metabolic indexes, including the levels of fasting plasma glucose, C-peptide and HbA1c, have been significantly improved while the requirement of insulin or oral hypoglycemic drugs was remarkably reduced. In addition to BMMSCs, the clinical relevance of MSCs derived from other sources in treating T2DM has also been assessed, which will provide alternative and more readily available sources.…”