Clinical Trial of Fat Grafts Supplemented With Adipose-derived Regenerative Cells
|Craniofacial Microsomia||Procedure: Supplementation of ADRC Procedure: Without supplementation of ADRC||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Clinical Trial of Fat Grafts Supplemented With Adipose-derived Regenerative Cells for Facial Soft Tissue Augmentation in Patients With Craniofacial Microsomia.|
- Graft volume retention [ Time Frame: 6 months postoperative ]Graft volume retention evaluated by CT-scan performed at the preoperative period and at 6-months postoperative
- Number of viable cells before and after the supplementation of the grafts [ Time Frame: immediate postoperative ]Number of viable cells in adipose tissue evaluated by trypan blue method immediately after surgery
|Study Start Date:||January 2010|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: With supplementation of ADRC
Fat graft with supplementation of ADRC
Procedure: Supplementation of ADRC
Isolation of ADRC from half of the aspirated fat and supplementation of the fat grafts with these cells
Other Name: Cell-assisted lipotransfer
Active Comparator: Without supplementation of ADRC
Fat grafts without supplementation of ADRC
Procedure: Without supplementation of ADRC
Standard fat graft preparation
Other Name: Structural fat grafting
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01674439
|Division of Plastic and Reconstructive Surgery|
|Sao Paulo, SP, Brazil, 01246000|
|Principal Investigator:||Daniela Y Tanikawa, MD||Division of Plastic and Reconstructive Surgery, University of São Paulo School of Medicine|