Clinical Trial of Fat Grafts Supplemented With Adipose-derived Regenerative Cells
Condition: Craniofacial Microsomia
MeSH terms: Goldenhar Syndrome; Fetal Growth Retardation
Study type: Interventional
Phase: Phase 2

Summary: 
      Although first reports of the clinical use of adipose-derived regenerative cells (ADRC)
      suggest that this approach may be feasible and effective for soft tissue augmentation, there
      is a lack of randomized, controlled clinical trials in the literature. Hence, this study
      aimed to investigate whether a novel protocol for isolation of ADRC and their use in
      combination with fat tissue improve the long-term retention of the grafts in patients with
      craniofacial microsomia.
    

Detailed description: 
      To overcome problems associated with fat grafting, such as unpredictable clinical results and
      a low rate of graft survival, many innovative efforts and refinements of surgical techniques
      have been reported. For example, condensation of living tissue and removal of unnecessary
      components have been performed by centrifugation, filtration or gravity sedimentation;
      external mechanical force has been used to expand the recipient tissue as well as the
      overlying skin envelope; and a recent experimental study has suggested that repeated local
      injections of erythropoietin might enhance retention of grafted fat.

      Based on the finding that aspirated fat tissue contains a much smaller number of
      adipose-derived regenerative cells (ADRC) compared with intact tissue and that these cells
      play pivotal roles in the adipose tissue remodeling after lipoinjection, the supplementation
      of fat grafts with stromal vascular fraction isolated from adipose portion of liposuction
      aspirates has been proposed as a method to compensate its relative deficiency of ADRC.

      In the literature, there are at least three experimental studies demonstrating that
      supplementation of adipose progenitor cells enhances the volume or weight of surviving
      adipose tissue, and first reports of the clinical use of ADRC suggest that this approach may
      be feasible and effective for soft tissue augmentation.

      However, since these studies represent level of evidence IV, which correspond to the
      publication of case series, there is a lack of randomized, controlled clinical trials
      comparing this method to current standard techniques.

      Hence, this study aimed to fill this gap by investigating whether a novel protocol for
      isolation of ADRC and their use in combination with fat tissue improve the long-term
      retention of the grafts in patients with craniofacial microsomia.
    

Intervention name(s): Supplementation of ADRC; Without supplementation of ADRC
Intervention type(s): Procedure; Procedure
Intervention description(s): Isolation of ADRC from half of the aspirated fat and supplementation of the fat grafts with these cells; Standard fat graft preparation
Other intervention name(s): Cell-assisted lipotransfer; Structural fat grafting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adipose-derived regenerative cells; Cell therapy; Autologous fat transfer; Tissue engineering; Craniofacial microsomia