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

Randomized Controlled Clinical Trial of Fat Grafts Supplemented With Adipose-derived Regenerative Cells for Facial Soft Tissue Augmentation in Patients With Craniofacial Microsomia.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01674439
Enrollment
29
Registered
2012-08-28
Start date
2010-01-31
Completion date
2012-07-31
Last updated
2012-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniofacial Microsomia

Keywords

Adipose-derived regenerative cells, Cell therapy, Autologous fat transfer, Tissue engineering, Craniofacial microsomia

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 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 patients with craniofacial microsomia.

Interventions

PROCEDURESupplementation of ADRC

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

PROCEDUREWithout supplementation of ADRC

Standard fat graft preparation

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Unilateral craniofacial microsomia * 10 to 35 years old * Phenotype (M0, M1 or M2) and (S1 or S2) according to the OMENS-PLUS classification

Exclusion criteria

* Previous soft tissue surgery * Absence of fat donor site

Design outcomes

Primary

MeasureTime frameDescription
Graft volume retention6 months postoperativeGraft volume retention evaluated by CT-scan performed at the preoperative period and at 6-months postoperative

Secondary

MeasureTime frameDescription
Number of viable cells before and after the supplementation of the graftsimmediate postoperativeNumber of viable cells in adipose tissue evaluated by trypan blue method immediately after surgery

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026