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

NCT03806361 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-10-18

No results posted yet for this study

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

Interventions

PROCEDURE

Fat grafts supplemented with ADRC

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

PROCEDURE

Structural fat grafting

Fat grafts without supplementation of ADRC

Sponsors & Collaborators

  • Hospital Sirio-Libanes

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-10
Primary Completion
2021-01-10
Completion
2021-01-10

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03806361 on ClinicalTrials.gov