Adipose Tissue Derived Stromal Vascular Fraction (SVF) Application in Treatment of Long Bones Nonunion
Condition: Nonunion of Fracture
MeSH terms: Fractures, Ununited
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Nonunion is a major complication of fractures.Per cutaneous bone marrow concentrate (BMC)
      application around fracture ends is being utilized with great success . Mesenchymal Stem
      Cells (MSCs)are one of the major cell types found in BMC responsible for results Adipose
      tissue is an alternative source for MSCs. Besides abundant and readily accessible it also
      overcomes issue of morbidity with bone marrow aspiration.

      this retrospective analysis to report the outcome in patients treated with fluoroscopic
      guided percutaneous injection of SVF at the site of fracture as an outpatient procedure
      between November 2012 to August 2018.
    

Detailed description: 
      Nonunion is of major complication of fractures .The overall rate of non-union is still not
      clear but estimates from the published literature suggests a range between 5-10% of the total
      fractures.The gap in non-healing management has instigated the search for novel
      osteo-inductive substances. bone marrow concentrate is being utilized for many year with
      excellent results .Mesenchymal Stem Cells (MSCs)are one of the major cell types of the Bone
      Marrow Aspirate Concentrate (BMAC)that self-renovates and differentiates into multiple cell
      types of mesodermal origin such as osteoblasts, chondrocytes, and adipocytes.

      Adipose tissue is an alternative source for MSCs .besides abundant and readily accessible it
      also overcomes issue of morbidity with bone marrow aspiration.

      This retrospective analysis was conducted to report the outcome in patients treated with
      fluoroscopic guided percutaneous injection of SVF at the site of fracture as an outpatient
      procedure between November 2012 to August 2018.

      The purpose of this study is to report the feasibility of minimally invasive percutaneous
      injection with autologous SVF and study the osteo-inductive efficacy of Adipose derived
      stromal cells in SVF in the management of non-union.
    

Intervention name(s): autologous adipose tissue derived stromal vascular fraction (SVF)
Intervention type(s): Biological
Intervention description(s): liquid and solid portion of lipo-aspirate after non enzymatic processing yields SVF.
This isolation process yielded an abundant population of Adipose stromal cells(ASCs) which have multipotent differentiation potential. Immunophenotype is a CD14-, CD29+, CD31-, CD34low/+, CD45-, CD73+ and CD105+ ,
, the SVF represents the 50-70% in volume of a lipoaspirate specimen. The SVF hosts a heterogeneous cell population (110x103 cells/ml on average) comprising mainly CD105+ mesenchymal stem cells (MSC, 20%), plus a wide number of CD34+ hematopoietic cells (40%).
Intervention model: Single Group Assignment
Intervention model description: retrospective study to report the outcome in patients treated with fluoroscopic guided per cutaneous injection of Adipose tissue derived stromal vascular fraction (SVF) at the site of fracture as an outpatient procedure between November 2012 to August 2018.
The indication for this procedure was established atrophic non-union with no evidence of infection with maximum gap between the fragments to be<5 mm and duration not later than one year between the fracture and the procedure.
Healing at the injury site was evaluated using clinical and radio logical examination at 1,2,6, and 12 months post-treatment.Anterior-posterior radio graphs
Masking: None (Open Label)
Primary purpose: Treatment