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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Autologous Bone Marrow Mononuclear cell Infusion Combined With Hyperbaric Oxygen Therapy
Autologous Bone Marrow Mononuclear cell Infusion
Hyperbaric Oxygen Therapy
hypoglycemic drugs or exogenous insulin
Fuzhou General Hospital
Fuzhou, Fujian, China
area under the curve of c-peptide
Time frame: 1 year
The incidence and severity of adverse events related to the stem cell infusion procedure
Time frame: 1 year
The incidence and severity of adverse events related to the hyperbaric oxygen therapy
Time frame: 1 year
HbA1c
Time frame: 1 year
exogenous insulin requirements
Time frame: 1 year
fasting hemoglucose
Time frame: 1 year
fasting c-peptide
Time frame: 1 year
area under the curve of serum insulin
Time frame: 1 year
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