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Clinical Trial of Fat Grafts Supplemented With Adipose-derived Regenerative Cells

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ClinicalTrials.gov Identifier: NCT01674439
Recruitment Status : Completed
First Posted : August 28, 2012
Last Update Posted : August 28, 2012
Sponsor:
Information provided by (Responsible Party):
Daniela Y. S. Tanikawa, University of Sao Paulo

August 22, 2012
August 28, 2012
August 28, 2012
January 2010
July 2012   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Clinical Trial of Fat Grafts Supplemented With Adipose-derived Regenerative Cells
Randomized Controlled Clinical Trial of Fat Grafts Supplemented With Adipose-derived Regenerative Cells for Facial Soft Tissue Augmentation in Patients With Craniofacial Microsomia.
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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Craniofacial Microsomia
  • 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
  • Procedure: Without supplementation of ADRC
    Standard fat graft preparation
    Other Name: Structural fat grafting
  • Experimental: With supplementation of ADRC
    Fat graft with supplementation of ADRC
    Intervention: Procedure: Supplementation of ADRC
  • Active Comparator: Without supplementation of ADRC
    Fat grafts without supplementation of ADRC
    Intervention: Procedure: Without supplementation of ADRC

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
Same as current
July 2012
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Unilateral craniofacial microsomia
  • 10 to 35 years old
  • Phenotype (M0, M1 or M2) and (S1 or S2) according to the OMENS-PLUS classification

Exclusion Criteria:

  • Previous soft tissue surgery
  • Absence of fat donor site
Sexes Eligible for Study: All
10 Years to 35 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01674439
1069/08
CEPID-FAPESP 98/14254-2 ( Other Grant/Funding Number: CEPID-FAPESP 98/14254-2 )
No
Not Provided
Not Provided
Daniela Y. S. Tanikawa, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Daniela Y Tanikawa, MD Division of Plastic and Reconstructive Surgery, University of São Paulo School of Medicine
University of Sao Paulo
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP