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

Study Overview
=================
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.

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.

Conditions
-----------------
Craniofacial Microsomia

Intervention / Treatment
-----------------
* Procedure: Supplementation of ADRC
* Procedure: Without supplementation of ADRC


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With supplementation of ADRC<br>Fat graft with supplementation of ADRC | Procedure: Supplementation of ADRC<br>* Isolation of ADRC from half of the aspirated fat and supplementation of the fat grafts with these cells<br>* Other names: Cell-assisted lipotransfer;|
| Active Comparator: Without supplementation of ADRC<br>Fat grafts without supplementation of ADRC | Procedure: Without supplementation of ADRC<br>* Standard fat graft preparation<br>* Other names: Structural fat grafting;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft volume retention | Graft volume retention evaluated by CT-scan performed at the preoperative period and at 6-months postoperative | 6 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | immediate postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adipose-derived regenerative cells, Cell therapy, Autologous fat transfer, Tissue engineering, Craniofacial microsomia