Type 2 Diabetes Mellitus

Clinical Trial – 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:

Clinical Trial – Bone Marrow Mononuclear Cell and Hyperbaric Oxygen Therapy in Diabetes Mellitus

There were evidences that the non-immune mediated inflammatory pathways of cell damage
occurred in vitro in human islets upon hyperglycemia in type 2 diabetes mellitus. Autologous
stem cell therapies were an emerging set of therapies that showed promise with a low side
effect profile. we hypothesized that infusion of mononuclear cells from buffy coat obtained
from bone marrow might provide multiple signals for regeneration and inflammation-induced
lesion recovery of local tissues, of which the effect might be maximized by intra-arterial
pancreatic infusion through angiography and combination with hyperbaric oxygen therapy.

This trail includes a foregoing sub-trial that investigate the feasibility and safety of a
novel method for massive bone marrow collection. The traditional BM collecting procedure is
unfavorable because it yields minor bone marrow. Studies have shown that physiological
exercise can increase bone marrow blood flow, which might facilitate BM collection.

We plan to include a total of 60 patients with type 2 diabetes and randomly assign them to
either a control group or an exercise group (n =30 each). The patients in the exercise group
exercised 30 minutes before the operation. All patients underwent routine surgical care. The
collected BM volume, operation time, collecting speed , puncture times and pain scores during
the operation were recorded. Bone marrow samples were tested for CD34+ flow cytometry and
whole blood cell count.

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