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

This study has been completed.
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
Rodolfo Alejandro, University of Miami
ClinicalTrials.gov Identifier:
NCT01786707
First received: February 5, 2013
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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:


Condition Intervention Phase
Type 2 Diabetes Mellitus
Biological: Autologous stem cells and hyperbaric oxygen therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 2 Study of Autologous Stem Cell and Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • The Reduction in HbA1c From Time of Randomization to 1 Year After Intervention. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Proportion of Subjects With a Reduction of >1% in HbA1c [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: July 2009
Study Completion Date: March 2013
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous SC and HOT
Autologous stem cells and hyperbaric oxygen therapy
Biological: Autologous stem cells and hyperbaric oxygen therapy
Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT.
No Intervention: Control group
Patients in a control group will continue with standard medical treatment (SMT)

Detailed Description:

This is a phase I/II, prospective, randomized case controlled study in patients with Type 2 Diabetes Mellitus (T2DM) that seeks to investigate whether the combination of intrapancreatic Autologous Stem Cell infusion (ASC) and Hyperbaric Oxygen treatment (HBO) can improve glycemic control and pancreatic function in T2DM patients compared to controls receiving standard medical treatment (SMT) with metformin and insulin alone.

New therapies that lead to stopping ß-cell damage and possible ß-cell regeneration may decrease the incidence and progression of T2DM chronic complications and together with achievable life style changes may improve general health and quality of life of T2DM patients. Preliminary data from a pilot study involving 25 subjects with T2DM that underwent a combined treatment using ASC+HBO showed a significant progressive and consistent reduction in plasma glucose and HbA1c with an increase in C-peptide in conjunction with a decrease in the number and dose of oral agents and/or insulin. These encouraging preliminary results require confirmation in a controlled, randomized prospective trial.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 T2DM 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: SBP >140 mmHg or DBP >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 TB. 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 INR >1.5, PTT >40, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01786707

Locations
United States, Florida
Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
Rodolfo Alejandro
University of Miami
Investigators
Principal Investigator: Rodolfo Alejandro, MD Diabetes Research Institute, University of Miami Miller School of Medicine
  More Information

No publications provided

Responsible Party: Rodolfo Alejandro, Director, Clinical Islet Transplant Program, Diabetes Research Institute, University of Miami
ClinicalTrials.gov Identifier: NCT01786707     History of Changes
Other Study ID Numbers: IND 13724
Study First Received: February 5, 2013
Results First Received: December 20, 2013
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
Type 2 Diabetes Mellitus
Hyperbaric oxygen therapy (HOT)
Autologous Bone Marrow-Derived Buffy Coat
Stem cells (SC)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 19, 2014