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

NCT03806361 | Completed

• 1 other identifier: Hospital Sirio Libanes
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Craniofacial Microsomia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of viable cells

  Intraoperative and immediate postoperative period

Study Arms (2)

With ADRC

EXPERIMENTAL

Supplementation of fat grafts with ADRC

Procedure: Fat grafts supplemented with ADRC

Structural

ACTIVE COMPARATOR

Structural fat grafting

Procedure: Structural fat grafting

Interventions

Fat grafts supplemented with ADRC PROCEDURE

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

With ADRC

Structural fat grafting PROCEDURE

Fat grafts without supplementation of ADRC

Structural

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Study Sites (1)

Hospital Municipal Infantil Menino Jesus

São Paulo, São Paulo, 01329-010, Brazil

Location

MeSH Terms

Conditions

Goldenhar Syndrome

Condition Hierarchy (Ancestors)

Mandibulofacial Dysostosis; Craniofacial Dysostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects will not know which treatment they will receive, outcome assessors will also be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized, controlled, clinical trial with 2 parallel comparison groups

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 16, 2019
• Study Start: January 10, 2019
• Primary Completion: January 10, 2021
• Study Completion: January 10, 2021
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)