NCT01674439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
Last Updated

August 28, 2012

Status Verified

August 1, 2012

Enrollment Period

2.5 years

First QC Date

August 22, 2012

Last Update Submit

August 27, 2012

Conditions

Craniofacial Microsomia

Keywords

Adipose-derived regenerative cellsCell therapyAutologous fat transferTissue engineeringCraniofacial microsomia

Outcome Measures

Primary Outcomes (1)

  • Graft volume retention

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

    6 months postoperative

Secondary Outcomes (1)

  • Number of viable cells before and after the supplementation of the grafts

    immediate postoperative

Study Arms (2)

With supplementation of ADRC

EXPERIMENTAL

Fat graft with supplementation of ADRC

Procedure: Supplementation of ADRC

Without supplementation of ADRC

ACTIVE COMPARATOR

Fat grafts without supplementation of ADRC

Procedure: Without supplementation of ADRC

Interventions

Supplementation of ADRCPROCEDURE

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

Also known as: Cell-assisted lipotransfer
With supplementation of ADRC
Without supplementation of ADRCPROCEDURE

Standard fat graft preparation

Also known as: Structural fat grafting
Without supplementation of ADRC

Eligibility Criteria

Age10 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Previous soft tissue surgery
  • Absence of fat donor site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Plastic and Reconstructive Surgery

São Paulo, São Paulo, 01246000, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 17763894RESULT

  • 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.

    PMID: 18513295RESULT

  • 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.

    PMID: 19912236RESULT

  • 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.

    PMID: 21999260RESULT

MeSH Terms

Conditions

Goldenhar Syndrome

Condition Hierarchy (Ancestors)

Mandibulofacial DysostosisCraniofacial DysostosisDysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Daniela Y Tanikawa, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assistant Physician

Study Record Dates

First Submitted

August 22, 2012

First Posted

August 28, 2012

Study Start

January 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 28, 2012

Record last verified: 2012-08

Locations

BR(1)