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

Primary Purpose

Craniofacial Microsomia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Fat grafts supplemented with ADRC
Structural fat grafting
Sponsored by
Hospital Sirio-Libanes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Craniofacial Microsomia

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Municipal Infantil Menino Jesus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

With ADRC

Structural

Arm Description

Supplementation of fat grafts with ADRC

Structural fat grafting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
January 9, 2019
Last Updated
October 15, 2021
Sponsor
Hospital Sirio-Libanes
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1. Study Identification

Unique Protocol Identification Number
NCT03806361
Brief Title
Fat Grafts With Adipose-derived Regenerative Cells for Soft Tissue Reconstruction in Children
Official Title
Fat Grafts Supplemented With Adipose-derived Regenerative Cells for Soft Tissue Reconstruction in Children With Craniofacial Microsomia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
January 10, 2021 (Actual)
Study Completion Date
January 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sirio-Libanes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 paediatric 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 paediatric patients with craniofacial microsomia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniofacial Microsomia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, clinical trial with 2 parallel comparison groups
Masking
ParticipantOutcomes Assessor
Masking Description
Subjects will not know which treatment they will receive, outcome assessors will also be blinded.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With ADRC
Arm Type
Experimental
Arm Description
Supplementation of fat grafts with ADRC
Arm Title
Structural
Arm Type
Active Comparator
Arm Description
Structural fat grafting
Intervention Type
Procedure
Intervention Name(s)
Fat grafts supplemented with ADRC
Intervention Description
Isolation of ADRC from fat aspirates and its use for supplementation of fat grafts.
Intervention Type
Procedure
Intervention Name(s)
Structural fat grafting
Intervention Description
Fat grafts without supplementation of ADRC
Primary Outcome Measure Information:
Title
Volumetric analysis of both hemifaces
Description
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.
Time Frame
Preoperative, 1 month postoperative, 3 months postoperative and 6 months postoperative
Secondary Outcome Measure Information:
Title
Number of viable cells
Description
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).
Time Frame
Intraoperative and immediate postoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Municipal Infantil Menino Jesus
City
São Paulo
State/Province
SP
ZIP/Postal Code
01329-010
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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