The purpose of this study is to determine whether intravenous administration of autologous adipose stem cells is safe and beneficial in patients with type 1 diabetes.
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 I/II study is to determine whether the intravenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe and efficacious in patients with Type 1 Diabetes Mellitus. Patients will be observed over 12 months following the procedure, with 2 weeks, 1 month and tri-monthly diagnostics and life style questionaires.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
RECRUITINGVeterens Memorial Medical Centre
Quezon City, Manila, Philippines
RECRUITINGLowering of insulin-dependence and anti-hyperglycemic medication dosages
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
Increased circulating C-Peptide levels
Time frame: At 4, 12, 24, 36, and 48 weeks.
Increased general well-being of patients.
Time frame: At 2, 4, 12, 24, 36, and 48 weeks.
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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