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

NCT ID: NCT03806361

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2021-01-10

Brief Summary

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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

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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.

Conditions

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Craniofacial Microsomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, clinical trial with 2 parallel comparison groups
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Subjects will not know which treatment they will receive, outcome assessors will also be blinded.

Study Groups

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With ADRC

Supplementation of fat grafts with ADRC

Group Type EXPERIMENTAL

Fat grafts supplemented with ADRC

Intervention Type PROCEDURE

Isolation of ADRC from fat aspirates and its use for supplementation of fat grafts.

Structural

Structural fat grafting

Group Type ACTIVE_COMPARATOR

Structural fat grafting

Intervention Type PROCEDURE

Fat grafts without supplementation of ADRC

Interventions

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Fat grafts supplemented with ADRC

Isolation of ADRC from fat aspirates and its use for supplementation of fat grafts.

Intervention Type PROCEDURE

Structural fat grafting

Fat grafts without supplementation of ADRC

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Sirio-Libanes

OTHER

Sponsor Role lead

Responsible Party

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Daniela S Tanikawa

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Municipal Infantil Menino Jesus

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Hospital Sirio Libanes

Identifier Type: -

Identifier Source: org_study_id