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Sponsored by: |
Adistem Ltd |
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Information provided by: | Adistem Ltd |
ClinicalTrials.gov Identifier: | NCT00703612 |
The purpose of this study is to determine whether intravenous administration of autologous adipose-derived stem cells is of benefit in the management of types 2 diabetics.
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus |
Procedure: Autologous Adipose-derived Stem cells |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 2 Diabetes |
Enrollment: | 34 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Treatment Group: Experimental
This is the only arm and that is the treatment group.
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Procedure: Autologous Adipose-derived Stem cells
Intravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue.
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Diabetes Mellitus is of large epidemic proportions worldwide. It is proliferating at such a fast rate that new novel drugs and other therapeutic approaches are required. The purpose of this Phase 1/Phase 2 study is to determine whether the intavenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe to and can benefit the disease pathology of patients with Type 2 Diabetes Mellitus (insulin resistance). Patients will be observed over 12 months following the procedure, with a 2 week, 1 month and then tri monthly diagnostics and life style questionaires.
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Philippines, Manila | |
Beverly Hills Medical Group | |
Makati City, Manila, Philippines, 1223 | |
Veterens Memorial Medical Centre | |
Quezon City, Manila, Philippines, 1229 |
Principal Investigator: | Emeritta A Barrenechea, MD | Veterens Memorial Medical Centre, Philippines |
Principal Investigator: | Florencio Q Lucero, MD | University of Philippines, College of Medicine. |
Study Director: | Letitia Lucero-Palma, MD | Far Eastern University-NRMF Hospital, Quezon City, Philippines |
Study Chair: | Bill Paspaliaris, PhD | Adistem Ltd |
Responsible Party: | Adistem Ltd ( Bill Paspaliaris / Director ) |
Study ID Numbers: | Adis-002 |
Study First Received: | June 19, 2008 |
Last Updated: | June 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00703612 History of Changes |
Health Authority: | Philippines: Department of Health |
Diabetes Mellitus Adipose-derived stem cells Adipose stromal vascular fraction Autologous Hyperglycemia |
Metabolic Diseases Hyperglycemia Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |