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

U

University of Sao Paulo

Status and phase

Completed
Phase 2

Conditions

Craniofacial Microsomia

Treatments

Procedure: Supplementation of ADRC
Procedure: Without supplementation of ADRC

Study type

Interventional

Funder types

Other

Identifiers

NCT01674439
1069/08
CEPID-FAPESP 98/14254-2 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

29 patients

Sex

All

Ages

10 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

29 participants in 2 patient groups

With supplementation of ADRC
Experimental group
Description:
Fat graft with supplementation of ADRC
Treatment:
Procedure: Supplementation of ADRC
Without supplementation of ADRC
Active Comparator group
Description:
Fat grafts without supplementation of ADRC
Treatment:
Procedure: Without supplementation of ADRC

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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