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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: |
NCT00703599 |
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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 Patients With Type 1 Diabetes
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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 1 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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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00703599 |
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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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Letitia Lucero-Palma, MD |
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Address:
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Telephone:
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63-916-478-7512 |
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Email:
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lettielucero@yahoo.com |
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Affiliation:
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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, Hong Kong |
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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 I diabetes for at least 2 years
- Insulin-dependent
Exclusion Criteria:
- Presence of acute diabetic complications in the acute stage as recent myocardial
infarction, recent CVA or acute renal failure.
Age minimum:
16 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 1 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 insulin-dependence and anti-hyperglycemic medication dosages
[Time Frame: At 2, 4, 12, 24, 36, and 48 weeks]
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Secondary Outcome(s)
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Increased circulating C-Peptide levels
[Time Frame: At 4, 12, 24, 36, and 48 weeks.]
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Increased 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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No detrimental change seen in kidney function tests, liver function tests and other haematological parameters.
[Time Frame: At 2, 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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