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

Phase 2

Completed

• Conditions: Craniofacial Microsomia
• Interventions: Procedure: Supplementation of ADRC; Procedure: Without supplementation of ADRC

• Registration Number: NCT01674439
• Lead Sponsor: University of Sao Paulo

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-08
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-27
• Last Update Submitted: 2012-08-27
• Study First Posted: 2012-08-28
• Last Update Posted: 2012-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

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Exclusion Criteria

• Previous soft tissue surgery
• Absence of fat donor site

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With supplementation of ADRC	Supplementation of ADRC	Fat graft with supplementation of ADRC
Without supplementation of ADRC	Without supplementation of ADRC	Fat grafts without supplementation of ADRC

Primary Outcome Measures

Name	Time	Method
Graft volume retention	6 months postoperative	Graft volume retention evaluated by CT-scan performed at the preoperative period and at 6-months postoperative

Secondary Outcome Measures

Name	Time	Method
Number of viable cells before and after the supplementation of the grafts	immediate postoperative	Number of viable cells in adipose tissue evaluated by trypan blue method immediately after surgery

Trial Locations

Locations (1)

Division of Plastic and Reconstructive Surgery; 🇧🇷 Sao Paulo, SP, Brazil