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

Primary Purpose

Craniofacial Microsomia

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Supplementation of ADRC
Without supplementation of ADRC
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Craniofacial Microsomia focused on measuring Adipose-derived regenerative cells, Cell therapy, Autologous fat transfer, Tissue engineering, Craniofacial microsomia

Eligibility Criteria

10 Years - 35 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • Division of Plastic and Reconstructive Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

With supplementation of ADRC

Without supplementation of ADRC

Arm Description

Fat graft with supplementation of ADRC

Fat grafts without supplementation of ADRC

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of viable cells before and after the supplementation of the grafts
Number of viable cells in adipose tissue evaluated by trypan blue method immediately after surgery

Full Information

First Posted
August 22, 2012
Last Updated
August 27, 2012
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01674439
Brief Title
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

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniofacial Microsomia
Keywords
Adipose-derived regenerative cells, Cell therapy, Autologous fat transfer, Tissue engineering, Craniofacial microsomia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With supplementation of ADRC
Arm Type
Experimental
Arm Description
Fat graft with supplementation of ADRC
Arm Title
Without supplementation of ADRC
Arm Type
Active Comparator
Arm Description
Fat grafts without supplementation of ADRC
Intervention Type
Procedure
Intervention Name(s)
Supplementation of ADRC
Other Intervention Name(s)
Cell-assisted lipotransfer
Intervention Description
Isolation of ADRC from half of the aspirated fat and supplementation of the fat grafts with these cells
Intervention Type
Procedure
Intervention Name(s)
Without supplementation of ADRC
Other Intervention Name(s)
Structural fat grafting
Intervention Description
Standard fat graft preparation
Primary Outcome Measure Information:
Title
Graft volume retention
Description
Graft volume retention evaluated by CT-scan performed at the preoperative period and at 6-months postoperative
Time Frame
6 months postoperative
Secondary Outcome Measure Information:
Title
Number of viable cells before and after the supplementation of the grafts
Description
Number of viable cells in adipose tissue evaluated by trypan blue method immediately after surgery
Time Frame
immediate postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Y Tanikawa, MD
Organizational Affiliation
Division of Plastic and Reconstructive Surgery, University of São Paulo School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Plastic and Reconstructive Surgery
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
17763894
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.
Results Reference
result
PubMed Identifier
18513295
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.
Results Reference
result
PubMed Identifier
19912236
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.
Results Reference
result
PubMed Identifier
21999260
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.
Results Reference
result

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

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