A Phase 2 interventional study of Supplementation of ADRC and Without supplementation of ADRC in Craniofacial Microsomia, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 10 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-28.
Sponsored by University of Sao Paulo · Phase 2, Interventional, and Treatment
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.
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.
264 studies on the registry are indexed under Fetal Growth Retardation; 66 are open to participants now.
This study's enrollment of 29 is below the median of 101 across 117 interventional studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Fat graft with supplementation of ADRC
Procedure: Supplementation of ADRC
Fat grafts without supplementation of ADRC
Procedure: Without supplementation of ADRC
Isolation of ADRC from half of the aspirated fat and supplementation of the fat grafts with these cells
Also known as: Cell-assisted lipotransfer
Standard fat graft preparation
Also known as: Structural fat grafting
Graft volume retention
Graft volume retention evaluated by CT-scan performed at the preoperative period and at 6-months postoperative
Time frame: 6 months postoperative
Number of viable cells before and after the supplementation of the grafts
Number of viable cells in adipose tissue evaluated by trypan blue method immediately after surgery
Time frame: immediate postoperative
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Goldenhar Syndrome
University of Sao Paulo