Fat Grafts With Adipose-derived Regenerative Cells for Soft Tissue Reconstruction in Children

Fat Grafts Supplemented With Adipose-derived Regenerative Cells for Soft Tissue Reconstruction in Children 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 paediatric patients with craniofacial microsomia.

Study Overview

• Status: Completed
• Conditions: Craniofacial Microsomia
• Intervention / Treatment: Procedure: Fat grafts supplemented with ADRC; Procedure: Structural fat grafting

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 paediatric patients with craniofacial microsomia.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 01329-010
      • Hospital Municipal Infantil Menino Jesus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Unilateral craniofacial microsomia
• 10 to 18 years old
• Phenotype: (M0, M1 or M2) and (S1 or S2) according to the OMENS-Plus classification

Exclusion Criteria:

• Previous facial soft tissue surgery
• Absence of fat donor site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: With ADRC; Supplementation of fat grafts with ADRC	Procedure: Fat grafts supplemented with ADRC; Isolation of ADRC from fat aspirates and its use for supplementation of fat grafts.
ACTIVE_COMPARATOR: Structural; Structural fat grafting	Procedure: Structural fat grafting; Fat grafts without supplementation of ADRC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric analysis of both hemifaces	Preoperative and 1, 3 and 6-months postoperative 3D-photogrammetry will be performed for volumetric measurements of both hemifaces using Vectra H1 software. Volumetric augmentation will be noticed for each patient by comparing the change between volumes of affected and unaffected hemifaces in the preoperative and 1, 3 and 6 months postoperative periods, which will be considered the retention volume. The percentage of fat graft survival will be determined as a ratio of the retention volume to the preoperative difference between volumes of affected and unaffected hemifaces.	Preoperative, 1 month postoperative, 3 months postoperative and 6 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of viable cells	Immediately after the surgical procedure the number of viable cells isolated before and after the supplementation of the grafts will be counted using the trypan blue dye exclusion assay in a Neubauer chamber using the light microscope Nikon Eclipse TS100 (Nikon Instruments Inc., NY, USA). Next, immunophenotype characterization of cell populations on passage 1 will be done by flow cytometric analysis with the anti-human antibodies CD29, CD31, CD45, CD90, CD73 and CD105 (Becton, Dickinson and Company, NJ, USA) in a Guava EasyCyte flow cytometer running the Guava Express Plus software (Guava Technologies Hayward, CA, USA).	Intraoperative and immediate postoperative period

Collaborators and Investigators

• Sponsor: Hospital Sirio-Libanes

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2019
• Primary Completion (ACTUAL): January 10, 2021
• Study Completion (ACTUAL): January 10, 2021

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (ACTUAL): January 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Fetal Diseases; Pregnancy Complications; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Growth Disorders; Bone Diseases, Developmental; Mandibulofacial Dysostosis; Craniofacial Dysostosis; Dysostoses; Fetal Growth Retardation; Goldenhar Syndrome
• Other Study ID Numbers: Hospital Sirio Libanes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No