Autologous Stem Cell and Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus

Inclusion Criteria

• Male and female patients age 45 to 65 years of age.
• Ability to provide written informed consent.
• Mentally stable and able to comply with the procedures of the study protocol.
• Clinical history compatible with type 2 diabetes as defined by the Expert Committee on the Diagnosis and classification of Diabetes Mellitus.
• Onset of Type 2 DM disease at 40 years of age.
• T2DM duration: 2-15 years at the time of enrollment.
• Basal C-peptide: 0.3 ng/mL
• HbA1c of 7.5-12.5% before standard medical therapy. Patients must have been treated with SMT for minimum of 4 months prior to randomization. Insulin and metformin doses should be stable over the 3 months prior to randomization.
• HbA1c: 7.5-9.5% at time of randomization.
• Total insulin daily dose at baseline and at randomization 40 kg/m2.
• Insulin requirements of >100 U/day, and HbA1c >9.5%
• C-reactive protein >10.00
• Uncontrolled blood pressure: Systolic Blood Pressure >140 mmHg or Diastolic Blood Pressure >80 mmHg Evidence of renal dysfunction, serum creatinine > 1.5 mg/dl (males) and 1.4 mg/dl (females)
• Proteinuria >300 mg/day
• History or EKG evidence of myocardial infarction or any degree of heart failure
• Female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study. Male participants: intent to procreate 3 months before or after the intervention or unwillingness to use effective measures of contraception.
• Active infection including hepatitis B, hepatitis C, HIV, or Tuberculosis. Positive tests are acceptable only if associated with a history of previous vaccination in the absence of any sign of active infection.
• Known active alcohol or substance abuse including cigarette/cigar smoking
• Baseline Hgb below the lower limits of normal at the local laboratory; lymphopenia ( 1.5, Partial thromboplastin time (PTT) >40, Prothrombin time (PT) >15.
• Acute or chronic pancreatitis.
• Symptomatic peptic ulcer disease.
• Hyperlipidemia despite medical therapy
• Receiving treatment for a medical condition requiring chronic use of systemic corticosteroids in the past six months.
• Symptomatic cholecystolithiasis.
• Use of any investigational agents within 4 weeks of enrollment.
• Admission to hospital for any reason in the 14 days prior to enrollment.
• History or presence of active proliferative diabetic retinopathy or macular edema.
• Any malignancy.
• Hepatic enzyme levels upper normal limits.
• Total bilirubin upper normal limits unless secondary to known benign condition.
• Abdominal aortic aneurysm.
• History of cerebro-vascular accident.
• Any patient with acute or subacute decompensation from diabetes.
• Any acute or chronic infectious condition that in the criteria of the investigator would be a risk for the patient.
• Hypoproteinemia, cachexia or terminal states; history of anorexia/bulimia; respiratory insufficiency; history of chronic sinusitis (sinusitis lasting more than 8 weeks in the past year) or recurrent acute sinusitis (sinusitis lasting more than 4 weeks more than four times in the past year.
• Any contraindication to hyperbaric oxygen treatment.
• Subjects treated with any medication that could interfere with the outcome of the study.
• Subjects positive for auto-antibodies
• History of Cushing syndrome (endogenous or iatrogenic).
• History of allergy to iodine or iodinated materials.
• Abnormal thyroid function
• Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.