This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal vascular fraction cells implantation via intravenous infusion. The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Type II Diabetes Mellitus.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.
Ageless Regenerative Institute LLC
Aventura, Florida, United States
Reduction of insulin requirement by > 50%
Time frame: 3 months and 6 months
Number of adverse events reported
The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.
Time frame: up to the 6-month period following treatment
Improvement of Hemoglobin A1c(HbA1c) levels as compared to baseline
Blood sample
Time frame: 3 months and 6 months
reduction in requirement of insulin dosage compared to baseline
Time frame: 3 months
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