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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00703612 |
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Date of registration:
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19/06/2008 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Type 2 Diabetics
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Scientific title:
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Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 2 Diabetes |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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34 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00703612 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Philippines
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Contacts
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Name:
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Bill Paspaliaris, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Adistem Ltd |
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Name:
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Letitia Lucero-Palma, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Far Eastern University-NRMF Hospital, Quezon City, Philippines |
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Name:
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Florencio Q Lucero, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Philippines, College of Medicine. |
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Name:
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Emeritta A Barrenechea, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Veterens Memorial Medical Centre, Philippines |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Confirmed diagnosis of Type II diabetes for at least 2 years
- Type 2 diabetics on oral hypoglycemic agents and/or insulin
- Fasting blood sugar of >200mg% on at least two occasions
- Willing to keep a weekly diary and undergo observation for 12 months
Exclusion Criteria:
- Presence of of previous and/or acute diabetic complications such as myocardial
infarction, CVA or nephropathy
Age minimum:
40 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Procedure: Autologous Adipose-derived Stem cells
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Primary Outcome(s)
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Lowering of blood glucose be it fasting, random or post prandial
[Time Frame: At 2, 4, 12, 24, 36, and 48 weeks]
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Secondary Outcome(s)
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Decrease in anti-hyperglycemic medication dosages.
[Time Frame: At 2, 4, 12, 24, 36, and 48 weeks.]
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Improvement in the general well-being of patients.
[Time Frame: At 2, 4, 12, 24, 36, and 48 weeks.]
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Lowering of glycosylated hemoglobin (HbA1C).
[Time Frame: At 4, 12, 24, 36, and 48 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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