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Autologous Fibroblast Transplantation in Facial Deformities

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ClinicalTrials.gov Identifier: NCT01115634
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Tracking Information
First Submitted Date  ICMJE May 1, 2010
First Posted Date  ICMJE May 4, 2010
Last Update Posted Date July 21, 2016
Study Start Date  ICMJE September 2008
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2010)
2-point shift in at least one treated area using a standardized 7-point photoguide [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Fibroblast Transplantation in Facial Deformities
Official Title  ICMJE Autologous Transplantation of Cultured Fibroblast for Facial Contour Deformities
Brief Summary Beautiful skin requires maintenance of proper care. Skin exercise, protections from direct sunlight or harsh wind, and maintaining a healthy diet are some of the ways of having a good and radiant skin. However despite all the care taken passage of time will bring about conditions that will automatically lead to skin aging, which may require certain therapeutic, care. Fibroblasts are cells that synthesize the extracellular matrix and collagen and play a critical role in wound healing and maintenance of healthy skin. Loosing of fibroblast cell is the main problem in aging and wrinkles and non-healed skin wounds. Therefore proliferation of skin fibroblast along with differentiation of stem cells in the skin tissue is the best method for healing.
Detailed Description

Autologous cultured fibroblast is derived from in vitro expansion of fibroblasts harvested from the patient's normal skin. Biopsies from behind a patient's ear are the source of fibroblasts, which are isolated, expanded through cell culture, and used for the correction of facial contour deformities such as nasolabial folds, glabellar crease, deep wrinkles of the forehead, and acne scars. Prior to final packaging, cell viability is assessed to be at least 85%.

Each single use container of autologous cultured fibroblasts has approximately 20 million cells aseptically processed and suspended in 1 mL of sterile, buffered Dulbecco's Modified Eagles Medium (DMEM). Both the biopsy transport media and the cell culture media contain gentamicin. Residual quantities of gentamicin up to 5 µg/mL may be present in the Cell product

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Nasolabial Folds
  • Glabellar Crease
  • Deep Wrinkles of the Forehead
  • Acne Scars
Intervention  ICMJE
  • Biological: Fibroblast
    20 million cell in three injection
    Other Name: cell alone
  • Biological: fibroblast and gel
    20 million cell in three injection plus filler
Study Arms  ICMJE Experimental: Fibroblast
Injection of autologous cultured fibroblast
Interventions:
  • Biological: Fibroblast
  • Biological: fibroblast and gel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2016)
60
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2010)
40
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Available and willing to attend all follow-up visits.
  • Age > 18 years.
  • Able and willing to give informed consent.

Exclusion Criteria:

  • Known allergy or sensitivity to collagen fillers
  • The subject has received a soft tissue augmentation to the area to be treated within the last 6 months.
  • Subject is unwilling to forgo any cosmetic augmentation procedures for the duration of the study.
  • The subject has received autologous fat transfer in the last 6 months.
  • Subject is suffering from facial Kaposi's sarcoma.
  • The subject has active skin diseases or inflammation on or near the area of injection
  • positive HIV, HBV, HCV
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01115634
Other Study ID Numbers  ICMJE Royan-skin-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royan Institute
Study Sponsor  ICMJE Royan Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Saeed Shafiyan, MD Royan Institute
Study Director: Nasser Aghdami, MD., PhD Royan Institute
PRS Account Royan Institute
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP