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First-in-Man Study - SVF Cells for Bone Fracture Healing Works!

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Review of “Implantation of Stromal Vascular Fraction Progenitors at Bone Fracture Sites: From a Rat Model to a First-in-Man Study” from Stem Cells by Stuart P. Atkinson

The stromal vascular fraction (SVF) of adipose tissue represents an ever growing (!) source of patient-specific stem cells with wide-ranging regenerative potential. The osteogenic and vasculogenic capacity of SVF cells makes them ideal for direct bone regeneration applications [1] and their direct application forgoes the need for ex vivo cell processing and expansion [2]. Additionally, SVF cell harvesting, loading onto osteoinductive scaffolds, and implanting into the same patient can take as little as 3-4 hours. 

This all led the teams of Ivan Martin and Arnaud Scherberich (University of Basel, Switzerland) to carry out a first-in-man study of bone fracture healing employing freshly harvested human SVF cells. Their results, recently published in Stem Cells [3], support larger controlled trials of SVF-based bone regeneration therapeutic strategies.

But before the first-in-man trial, Saxer et al first assessed their porous ceramic granules (osteoinductive scaffold) with fibrin-embedded human SVF cells approach utilizing a rat model. Some animals displayed signs of clinically stable healing and mineralized bridging between the SVF-graft and bone defect edges, while post-mortem analysis confirmed de novo bone formation and tissue vascularization repair.

This success promoted the application of this strategy in 8 elderly patients suffering from humeral fractures employing their own SVF cells derived from abdominal lipoaspirates. Encouragingly, the study did not note any graft-related adverse events or reactions or increases in pain assessments due to the graft or the liposuction process. Furthermore, all patients regained a pain-free range of movement sufficient for normal day-to-day tasks within 1 year and patient biopsies highlighted the existence of de novo bone formation, so demonstrating the overall success of the trial.

Encouraging news! This first-in-man study represents a great step towards the application of SVF cells to bone fracture healing. The authors demonstrate feasibility, safety, and bone formation and all without the requirement for in vitro cell expansion or exogenous priming! Hopefully larger, controlled trials will confirm the success of this SVF-based bone regeneration strategy. 

Keep an eye on the Stem Cells Portal to find out!

References

  1. Rhee SC, Ji YH, Gharibjanian NA, et al. In vivo evaluation of mixtures of uncultured freshly isolated adipose-derived stem cells and demineralized bone matrix for bone regeneration in a rat critically sized calvarial defect model. Stem Cells Dev 2011;20:233-242.
  2. Mehrkens A, Saxer F, Guven S, et al. Intraoperative engineering of osteogenic grafts combining freshly harvested, human adipose-derived cells and physiological doses of bone morphogenetic protein-2. Eur Cell Mater 2012;24:308-319.
  3. Saxer F, Scherberich A, Todorov A, et al. Implantation of Stromal Vascular Fraction Progenitors at Bone Fracture Sites: From a Rat Model to a First-in-Man Study. STEM CELLS 2016;34:2956-2966.