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Clinical Trial of Fat Grafts Supplemented With Adipose-derived Regenerative Cells

NCT01674439 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2012-08-28

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 patients with craniofacial microsomia.

Conditions

  • Craniofacial Microsomia

Interventions

PROCEDURE

Supplementation of ADRC

Isolation of ADRC from half of the aspirated fat and supplementation of the fat grafts with these cells

PROCEDURE

Without supplementation of ADRC

Standard fat graft preparation

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Daniela Y Tanikawa, MD · Division of Plastic and Reconstructive Surgery, University of São Paulo School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-07-31
Completion
2012-07-31

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 NCT01674439 on ClinicalTrials.gov