Clinical efficiency of autologous adipose-derived stromal vascular fraction cells and multipotent mesenchymal stromal cells for the treatment of patients with lower limb peripheral artery disease

Traditional pharmacological and surgical treatment of patients with chronic limb ischemia is ineffective in terms of their inadequate effect on microhemodynamics. In case direct reconstructive surgery is impossible, the transplantation of stem cells of different origin can be an alternative method of indirect limb revascularization. Autologous adipose-derived stem cells are an affordable and safe source of growth factors for improving tissue trophic as well as have high regenerative potential due to multipotent properties

Study aim: to improve the treatment of patients with lower limb peripheral artery disease by transplantation of autologous adipose-derived stromal vascular fraction cells and multipotent mesenchymal stromal cells

Primary Endpoint:

  • Safety of adipose-derived stromal vascular fraction cells and multipotent mesenchymal stromal cells transplantation
  • Safety and efficacy of cell injections were assessed by reviewing clinical outcomes and adverse events at 3-time points: (1) 1 months, (2) 3 months, and (3) 6 months follow-up
  • Major adverse events were adjudicated for observation: hospitalization, arterial thrombosis, limb amputation, multiple organ failure, death

Dosing regimen: local intramuscular multiple injections from 15•106to 40•106autologous adipose-derived stromal vascular fraction cells following [V1] intramuscular multiple injection from 5•106to 10•106autologous adipose-derived multipotent mesenchymal stromal cells (n = 8); control group – injection of autologous bone marrow aspirate [V2] (n = 18)

No HLA matching or immunosuppression required

Results. Transplantation of adipose-derived stem cells in patients with chronic limb ischemia improves microhemodynamics in ischemic muscles due to reparative angiogenesis that increases the pain-free walking distance, enhance the quality of life and promote social rehabilitation of patients

Publications:

  • Driuk NF, Kirimov VI, Barna IE, Dmitrenko IP, Shkuropat VN. Application of autologous aspirates as well as multipotent stromal cells of the bone marrow and adipose tissue in vascular surgery. Klin Khir. 2012 Dec;(12):24-9. [Article in Russian]
  • Poliachenko IuV, Driuk MF, Dombrovs’kyĭ DB. Ultrastructural changes of vascular endothelium in patients with chronic ischemia of the extremities after conduction of multipotent stromal cells from adipose tissue transplantation. Klin Khir. 2010 Jun;(6):50-3. [Article in Ukrainian]
  • Poliachenko IuV, Driuk MF, Dombrovs’kyĭ DB. Histological and immunohistochemical characteristics of stimulated angiogenesis in transplantation of multipotent stem cells derived from the adipose tissue in patients with chronic ischemia of the extremities. Klin Khir. 2010 May;(5):40-3. [Article in Ukrainian]
  • Dynnyk O, Mostoviy S, Dombrovsky DB, Salyutin RV. State of microcirculation for patients with the obliterans diseases of vessels of lower extremities at the terms of transplantation of multipotential stromal cells of fatty tissue. Bukovin. med. vіsn. – Bukovinian Medical Herald. 2010; 2(54):41-45. [Article in Ukrainian]
  • Polyachenko UV, Dryuk MF, Dombrovsky DB. Transplantation of multipotents stromal cells of fatty tissue, as a method of cellular stimulation of angiogenesis for patients with the chronic ischemia of extremities. Ukr. morfologіchnij al’manah – Ukr morph alm. 2010; 8(2):152-155. [Article in Ukrainian]
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