Critical Limb Ischemia Clinical Trial
Official title:
An Open-label, Non-Randomized, Patient Funded, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
This is an open-label, non-randomized, multi center, patient sponsored study of
Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who
have critical limb ischemia not amenable for revascularization.
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 critical limb ischemia ASCs will be collected from the patient's adipose-derived
tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the
adipose tissue specimen. The adipose tissue is then transferred to the laboratory for
separation of the adipose tissue derived stem cells. In addition, peripheral blood will be
collected for isolation of platelet rich plasma, which are then combined with the ASC's for
intramuscular injection into the lower limb.
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