Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus Hyperbaric oxygen therapy (HOT) Autologous Bone Marrow-Derived Buffy Coat Stem cells (SC)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2
Healthy volunteers: no

Brief summary:
A prospective, open labeled, randomized controlled clinical trial comparing the benefit of both hyperbaric oxygen therapy and intrapancreatic stem cell infusion to standard medical treatment alone for type 2 diabetes mellitus. Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months (evaluation phase). Then they will be randomized into either the intervention group or the control group:

Detailed description:
This is a phase I/II, prospective, randomized case controlled study in patients with Type 2 Diabetes Mellitus (T2DM) that seeks to investigate whether the combination of intrapancreatic Autologous Stem Cell infusion (ASC) and Hyperbaric Oxygen treatment (HBO) can improve glycemic control and pancreatic function in T2DM patients compared to controls receiving standard medical treatment (SMT) with metformin and insulin alone.

New therapies that lead to stopping ß-cell damage and possible ß-cell regeneration may decrease the incidence and progression of T2DM chronic complications and together with achievable life style changes may improve general health and quality of life of T2DM patients. Preliminary data from a pilot study involving 25 subjects with T2DM that underwent a combined treatment using ASC+HBO showed a significant progressive and consistent reduction in plasma glucose and HbA1c with an increase in C-peptide in conjunction with a decrease in the number and dose of oral agents and/or insulin. These encouraging preliminary results require confirmation in a controlled, randomized prospective trial.

Arms:
arm 1: Autologous stem cells and hyperbaric oxygen therapy arm 2: Patients in a control group will continue with standard medical treatment (Insulin and Metformin)

Interventions: intervention 1: Autologous stem cells intervention 2: Hyperbaric oxygen therapy intervention 3: Insulin intervention 4: Metformin
Intervention descriptions: intervention 1: Pancreatic artery infusion of Autologous Stem cells. intervention 2: None intervention 3: Insulin dose as per clinical management intervention 4: Metformin dose as tolerated

Protocol document: