Peripheral Arterial Disease Clinical Trial
Official title:
Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lower Limb Ischemia
Adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic digestion. 10 mL of autologous ADRC suspension injected intramuscularly, close to the site of muscle injury. All patients will receive cell therapy. This is a single arm study with no control.
Fat tissue obtainment:
Subjects will undergo liposuction under local anesthesia. In this procedure, Ringer's
solution with the anesthetic lidocaine and vasoconstrictor adrenaline infused into the
adipose compartment to minimize blood loss and contamination of the tissue by peripheral
blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced into the
subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe and
under gentle suction moved through the adipose compartment, mechanically disrupting the fat
tissue. Aspirate volume - approximately 150-200 cc. Procedure time - 30 minutes.
ADRC isolation:
Harvested adipose tissue will be processed according to patent pending technology based on
enzymatic digestion, washing and concentration of cell pellet in 10.5 ml of normal saline.
Obtained ADRC divided into 2 portions. First portion (0.5 mL) used for counting, viability
and sterility assessment. The second portion (10 ml) placed into sterile syringe for
injection.
Autologous ADRC administration
10 mL of autologous ADRC suspension will be injected intramuscularly, close to the site of
muscle injury. 10 to 20 injections (0.5 to 1.0 mL each) will be performed so as to
infiltrate the injured muscle.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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