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Autologous Fibroblast Grafts in Facial Skin Regeneration

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
LYDIA MASAKO FERREIRA, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01490554
First received: December 9, 2011
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the presence of skin changes after grafting of autologous fibroblasts by means of biophysical, histological, immunohistological, gene expression, glycosaminoglycan, and sensitivity analyses.


Condition Intervention
Skin Aging
 Procedure: autologous fibroblasts grafts

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Autologous Fibroblast Grafts in the Regeneration of Facial Ectoderm

Resource links provided by NLM:

MedlinePlus related topics: Skin Aging
U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Regeneration of facial ectoderm [ Time Frame: one year after the grafting of autologous fibroblasts. ] [ Designated as safety issue: Yes ]
    To evaluate the presence of skin changes after grafting of autologous fibroblasts by means of biophysical, histological, immunohistological, gene expression, glycosaminoglycan, and sensitivity analyses.


Enrollment: 20
Study Start Date: March 2007
Estimated Study Completion Date: December 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: autologous fibroblast grafts
autologous fibroblast grafts
 Procedure: autologous fibroblasts grafts
Autologous cultured fibroblasts will be grafted in facial skin

Detailed Description:

- Analytical prospective autocontrolled study

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women, aged between 50 to 70 years with facial wrinkles (rhytides),
  • Fitzpatrick III skin type, and
  • Who had reached menopause at least 3 years before entering the study were eligible for participation.

Exclusion Criteria:

  • Women with uncontrolled comorbid conditions,
  • Smokers,
  • Alcohol and corticosteroid users,
  • Who had undergone chemical peeling or skin filling in the face or neck at least 12 months prior to the study,
  • Who had a keloid scar,
  • Who scored below 18 on the Mini-Mental State Examination,
  • Who had any psychiatric disorder or those undergoing orthodontic treatment were excluded from the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490554

Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Lydia M Ferreira, MD, PhD Federal University of Sao Paulo
  More Information

No publications provided

Responsible Party: LYDIA MASAKO FERREIRA, Full Professor and Chairwoman and Head of the Division of Plastic Surgery and Department of Surgery, Federal University of Sao Paulo—UNIFESP, SP, Brazil, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01490554     History of Changes
Other Study ID Numbers: CEP UNIFESP-1787/07
Study First Received: December 9, 2011
Last Updated: July 23, 2012
Health Authority: Brazil : Research Ethics Committee
Brazil : ANVISA

Keywords provided by Federal University of São Paulo:
Skin aging
fibroblasts
transplantation
autologous

ClinicalTrials.gov processed this record on May 22, 2013