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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Intravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue.
Beverly Hills Medical Group
Makati City, Manila, Philippines
Veterens Memorial Medical Centre
Quezon City, Manila, Philippines
Lowering of blood glucose be it fasting, random or post prandial
Time frame: At 2, 4, 12, 24, 36, and 48 weeks
Decrease in anti-hyperglycemic medication dosages.
Time frame: At 2, 4, 12, 24, 36, and 48 weeks.
Improvement in the general well-being of patients.
Time frame: At 2, 4, 12, 24, 36, and 48 weeks.
Lowering of glycosylated hemoglobin (HbA1C).
Time frame: At 4, 12, 24, 36, and 48 weeks
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