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

NCT01786707 | Completed Phase 1 Results DMC

• 1 other identifier: 20070881
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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:

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Hyperbaric oxygen therapy (HOT); Autologous Bone Marrow-Derived Buffy Coat; Stem cells (SC)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Reduction of HbA1c of >0.5%

  1 year

Secondary Outcomes (1)

• The Number of Subjects With a Reduction of >1% in HbA1c

  at 1 year

Study Arms (2)

Autologous SC and HOT

EXPERIMENTAL

Autologous stem cells and hyperbaric oxygen therapy

Biological: Autologous stem cells; Other: Hyperbaric oxygen therapy; Drug: Insulin; Drug: Metformin

Control group

ACTIVE COMPARATOR

Patients in a control group will continue with standard medical treatment (Insulin and Metformin)

Drug: Insulin; Drug: Metformin

Interventions

Autologous stem cells BIOLOGICAL

Pancreatic artery infusion of Autologous Stem cells.

Autologous SC and HOT

Hyperbaric oxygen therapy OTHER

Autologous SC and HOT

Insulin DRUG

Insulin dose as per clinical management

Autologous SC and HOT; Control group

Metformin DRUG

Metformin dose as tolerated

Autologous SC and HOT; Control group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Rodolfo Alejandro: lead
• Diabetes Research Institute Foundation: collaborator

Study Sites (1)

Diabetes Research Institute, University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Hyperbaric Oxygenation; Insulin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Dr. Rodolfo Alejandro
• Organization: University of Miami School of Medicine

ralejand@med.miami.edu

3052435324

Study Officials

• Rodolfo Alejandro, MD

  Diabetes Research Institute, University of Miami Miller School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Clinical Islet Transplant Program, Diabetes Research Institute

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 8, 2013
• Study Start: July 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2013
• Last Updated: July 2, 2017
• Results First Posted: April 21, 2014

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)