Clinical Trial: Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lower Limb Ischemia

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lower Limb Ischemia

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Central Clinical Hospital with Outpatient Health Center of Business Administration for the President

Current Primary Outcome:

  • Serious adverse events [ Time Frame: 4 weeks after injection of ADRC suspension ]
    Frequency, type and severity of serious adverse events (SAE)
  • Serious adverse reactions [ Time Frame: 4 weeks after injection of ADRC suspension ]
    Frequency, type and severity of serious adverse reactions (SAR)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes of ankle-brachial index [ Time Frame: Follow up to completion (24 weeks after intervention) ]
    Influence of intervention on ankle-brachial index.
  • Changes of hemodynamics in lower extremity - 1 [ Time Frame: Follow up to completion (24 weeks after intervention) ]
    Influence of intervention on blood flow velocity assessed by arterial duplex scanning.
  • Changes of hemodynamics in lower extremity - 2 [ Time Frame: Follow up to completion (24 weeks after intervention) ]
    Influence of intervention on pulsatility index assessed by arterial duplex scanning.
  • Changes of hemodynamics in lower extremity - 3 [ Time Frame: Follow up to completion (24 weeks after intervention) ]
    Influence of intervention on resistance index assessed by arterial duplex scanning.
  • Metabolic state of targeted tissues measurements [ Time Frame: Follow up to completion (24 weeks after intervention) ]
    Changes of transcutaneous oxygen tension (ТсРО2) in injured limb assessed by transcutaneous oximetry.
  • Quality of life monitoring - 1 [ Time Frame: Follow up to completion (24 weeks after intervention) ]
    Quality of life estimated by validated questionnaire: the Short Form (SF-36).
  • Quality of life monitoring - 2 [ Time Frame: Follow up to completion (24 weeks after intervention) ]
    Quality of life estimated by validated questionnaire:Peripheral Artery Questionnaire.


Original Secondary Outcome: Same as current

Information By: Central Clinical Hospital with Outpatient Health Center of Business Administration for the President

Dates:
Date Received: August 5, 2016
Date Started: July 2016
Date Completion: July 2018
Last Updated: August 11, 2016
Last Verified: August 2016