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

Completed · Phase 1/Phase 2

Conditions studied: Type 2 Diabetes Mellitus

In brief

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:

Key facts

Study ID: NCT01786707
Run by: Rodolfo Alejandro
People needed: 2
Starts: 2009-07-01
Expected to finish: 2013-03-01
Last updated by the study team: 2017-07-02

Who can join

Age: 45 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 <100 units/day.

You may not qualify if…

BMI >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 (<1,000/L), neutropenia (<1,500/L), or thrombocytopenia (platelets <100,000/L).
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.
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.

Where it is running

Diabetes Research Institute, University of Miami Miller School of Medicine — Miami, Florida, United States

Full record on ClinicalTrials.gov

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