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

NCT ID: NCT01674439

Last Updated: 2012-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Craniofacial Microsomia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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With supplementation of ADRC

Fat graft with supplementation of ADRC

Group Type EXPERIMENTAL

Supplementation of ADRC

Intervention Type PROCEDURE

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

Without supplementation of ADRC

Fat grafts without supplementation of ADRC

Group Type ACTIVE_COMPARATOR

Without supplementation of ADRC

Intervention Type PROCEDURE

Standard fat graft preparation

Interventions

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Supplementation of ADRC

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

Intervention Type PROCEDURE

Without supplementation of ADRC

Standard fat graft preparation

Intervention Type PROCEDURE

Other Intervention Names

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Cell-assisted lipotransfer Structural fat grafting

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Daniela Y. S. Tanikawa

MD, Assistant Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniela Y Tanikawa, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Plastic and Reconstructive Surgery, University of São Paulo School of Medicine

Locations

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Division of Plastic and Reconstructive Surgery

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Yoshimura K, Sato K, Aoi N, Kurita M, Hirohi T, Harii K. Cell-assisted lipotransfer for cosmetic breast augmentation: supportive use of adipose-derived stem/stromal cells. Aesthetic Plast Surg. 2008 Jan;32(1):48-55; discussion 56-7. doi: 10.1007/s00266-007-9019-4. Epub 2007 Sep 1.

Reference Type RESULT
PMID: 17763894 (View on PubMed)

Yoshimura K, Sato K, Aoi N, Kurita M, Inoue K, Suga H, Eto H, Kato H, Hirohi T, Harii K. Cell-assisted lipotransfer for facial lipoatrophy: efficacy of clinical use of adipose-derived stem cells. Dermatol Surg. 2008 Sep;34(9):1178-85. doi: 10.1111/j.1524-4725.2008.34256.x. Epub 2008 May 29.

Reference Type RESULT
PMID: 18513295 (View on PubMed)

Yoshimura K, Asano Y, Aoi N, Kurita M, Oshima Y, Sato K, Inoue K, Suga H, Eto H, Kato H, Harii K. Progenitor-enriched adipose tissue transplantation as rescue for breast implant complications. Breast J. 2010 Mar-Apr;16(2):169-75. doi: 10.1111/j.1524-4741.2009.00873.x. Epub 2009 Nov 12.

Reference Type RESULT
PMID: 19912236 (View on PubMed)

Yoshimura K, Eto H, Kato H, Doi K, Aoi N. In vivo manipulation of stem cells for adipose tissue repair/reconstruction. Regen Med. 2011 Nov;6(6 Suppl):33-41. doi: 10.2217/rme.11.62.

Reference Type RESULT
PMID: 21999260 (View on PubMed)

Other Identifiers

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CEPID-FAPESP 98/14254-2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1069/08

Identifier Type: -

Identifier Source: org_study_id