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

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Hyperbaric oxygen therapy (HOT), Autologous Bone Marrow-Derived Buffy Coat, Stem cells (SC) Read More

Inclusion Criteria:

1. Male and female patients age 45 to 65 years of age.
2. Ability to provide written informed consent.
3. Mentally stable and able to comply with the procedures of the study protocol.
4. Clinical history compatible with type 2 diabetes as defined by the Expert Committee on the Diagnosis and classification of Diabetes Mellitus.
5. Onset of Type 2 DM disease at 40 years of age.
6. T2DM duration: 2-15 years at the time of enrollment.
7. Basal C-peptide: 0.3 ng/mL
8. 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.
9. HbA1c: 7.5-9.5% at time of randomization.
10. Total insulin daily dose at baseline and at randomization <100 units/day.

Exclusion Criteria:

1. BMI >40 kg/m2.
2. Insulin requirements of >100 U/day, and HbA1c >9.5%
3. C-reactive protein >10.00
4. 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)
5. Proteinuria >300 mg/day
6. History or EKG evidence of myocardial infarction or any degree of heart failure
7. 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.
8. 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.
9. Known active alcohol or substance abuse including cigarette/cigar smoking
10. Baseline Hgb below the lower limits of normal at the local laboratory; lymphopenia (<1,000/L), neutropenia (<1,500/L), or thrombocytopenia (platelets <100,000/L).
11. A history of Factor V deficiency or other coagulopathy defined by International normalized ratio (INR) >1.5, Partial thromboplastin time (PTT) >40, Prothrombin time (PT) >15.
12. Acute or chronic pancreatitis.
13. Symptomatic peptic ulcer disease.
14. Hyperlipidemia despite medical therapy
15. Receiving treatment for a medical condition requiring chronic use of systemic corticosteroids in the past six months.
16. Symptomatic cholecystolithiasis.
17. Use of any investigational agents within 4 weeks of enrollment.
18. Admission to hospital for any reason in the 14 days prior to enrollment.
19. History or presence of active proliferative diabetic retinopathy or macular edema.
20. Any malignancy.
21. Hepatic enzyme levels upper normal limits.
22. Total bilirubin upper normal limits unless secondary to known benign condition.
23. Abdominal aortic aneurysm.
24. History of cerebro-vascular accident.
25. Any patient with acute or subacute decompensation from diabetes.
26. Any acute or chronic infectious condition that in the criteria of the investigator would be a risk for the patient.
27. 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.
28. Any contraindication to hyperbaric oxygen treatment.
29. Subjects treated with any medication that could interfere with the outcome of the study.
30. Subjects positive for auto-antibodies
31. History of Cushing syndrome (endogenous or iatrogenic).
32. History of allergy to iodine or iodinated materials.
33. Abnormal thyroid function
34. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.