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

NCT01786707 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-07-02

Study results available
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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

Interventions

BIOLOGICAL

Autologous stem cells

Pancreatic artery infusion of Autologous Stem cells.

OTHER

Hyperbaric oxygen therapy

DRUG

Insulin

Insulin dose as per clinical management

DRUG

Metformin

Metformin dose as tolerated

Sponsors & Collaborators

  • Diabetes Research Institute Foundation

    collaborator OTHER

  • Rodolfo Alejandro

    lead OTHER

Principal Investigators

  • Rodolfo Alejandro, MD · Diabetes Research Institute, University of Miami Miller School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01786707 on ClinicalTrials.gov