Type 2 Diabetes Mellitus Clinical Trial
Official title:
Phase 2 Study of Autologous Stem Cell and Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus
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:
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.
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