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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniela Y. S. Tanikawa, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01674439
First received: August 22, 2012
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Craniofacial Microsomia
Procedure: Supplementation of ADRC
Procedure: Without supplementation of ADRC
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Graft volume retention [ Time Frame: 6 months postoperative ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: immediate postoperative ] [ Designated as safety issue: Yes ]
    Number of viable cells in adipose tissue evaluated by trypan blue method immediately after surgery


Enrollment: 29
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: With supplementation of ADRC
Fat graft with supplementation of ADRC
Procedure: Supplementation of ADRC
Isolation of ADRC from half of the aspirated fat and supplementation of the fat grafts with these cells
Other Name: Cell-assisted lipotransfer
Active Comparator: Without supplementation of ADRC
Fat grafts without supplementation of ADRC
Procedure: Without supplementation of ADRC
Standard fat graft preparation
Other Name: Structural fat grafting

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

Ages Eligible for Study:   10 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674439

Locations
Brazil
Division of Plastic and Reconstructive Surgery
Sao Paulo, SP, Brazil, 01246000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Daniela Y Tanikawa, MD Division of Plastic and Reconstructive Surgery, University of São Paulo School of Medicine
  More Information

Publications:
Responsible Party: Daniela Y. S. Tanikawa, MD, Assistant Physician, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01674439     History of Changes
Other Study ID Numbers: 1069/08, CEPID-FAPESP 98/14254-2
Study First Received: August 22, 2012
Last Updated: August 27, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Adipose-derived regenerative cells
Cell therapy
Autologous fat transfer
Tissue engineering
Craniofacial microsomia

Additional relevant MeSH terms:
Goldenhar Syndrome
Fetal Growth Retardation
Mandibulofacial Dysostosis
Craniofacial Dysostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014