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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
10 mL of autologous ADRC suspension will be injected intramuscularly
ADRC will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 10 ml of normal saline.
Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
Moscow, Russia
Serious adverse events
Frequency, type and severity of serious adverse events (SAE)
Time frame: 4 weeks after injection of ADRC suspension
Serious adverse reactions
Frequency, type and severity of serious adverse reactions (SAR)
Time frame: 4 weeks after injection of ADRC suspension
Changes of ankle-brachial index
Influence of intervention on ankle-brachial index.
Time frame: Follow up to completion (24 weeks after intervention)
Changes of hemodynamics in lower extremity - 1
Influence of intervention on blood flow velocity assessed by arterial duplex scanning.
Time frame: Follow up to completion (24 weeks after intervention)
Changes of hemodynamics in lower extremity - 2
Influence of intervention on pulsatility index assessed by arterial duplex scanning.
Time frame: Follow up to completion (24 weeks after intervention)
Changes of hemodynamics in lower extremity - 3
Influence of intervention on resistance index assessed by arterial duplex scanning.
Time frame: Follow up to completion (24 weeks after intervention)
Metabolic state of targeted tissues measurements
Changes of transcutaneous oxygen tension (ТсРО2) in injured limb assessed by transcutaneous oximetry.
Time frame: Follow up to completion (24 weeks after intervention)
Quality of life monitoring - 1
Quality of life estimated by validated questionnaire: the Short Form (SF-36).
Time frame: Follow up to completion (24 weeks after intervention)
Quality of life monitoring - 2
Quality of life estimated by validated questionnaire:Peripheral Artery Questionnaire.
Time frame: Follow up to completion (24 weeks after intervention)
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