Clinical trial NCT01674439: Clinical Trial of Fat Grafts Supplemented With Adipose-derived Regenerative Cells
Official title: Randomized Controlled Clinical Trial of Fat Grafts Supplemented With Adipose-derived Regenerative Cells for Facial Soft Tissue Augmentation in Patients With Craniofacial Microsomia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Craniofacial Microsomia
Keywords: Adipose-derived regenerative cells
Cell therapy
Autologous fat transfer
Tissue engineering
Craniofacial microsomia
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-08-28
Enrollment: 29
Sex: ALL
Minimum age (years): 10
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Graft volume retention
timeFrame: 6 months postoperative
Secondary outcomes:
measure: Number of viable cells before and after the supplementation of the grafts
timeFrame: immediate postoperative
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Division of Plastic and Reconstructive Surgery
state: SP
Study officials:
affiliation: Division of Plastic and Reconstructive Surgery, University of São Paulo School of Medicine
name: Daniela Y Tanikawa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.