Autologous Fibroblast Transplantation in Facial Deformities

This study has been completed.
Sponsor:
Information provided by:
Royan Institute
ClinicalTrials.gov Identifier:
NCT01115634
First received: May 1, 2010
Last updated: July 14, 2011
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Nasolabial Folds
Glabellar Crease
Deep Wrinkles of the Forehead
Acne Scars
Biological: Fibroblast
Biological: fibroblast and gel
Biological: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Autologous Transplantation of Cultured Fibroblast for Facial Contour Deformities

Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • 2-point shift in at least one treated area using a standardized 7-point photoguide [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: September 2008
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fibroblast
Injection of autologous cultured fibroblast
Biological: Fibroblast
20 million cell in three injection
Other Name: cell alone
Experimental: Fibroblast and gel
Injection of autologous cultured fibroblast and filler
Biological: fibroblast and gel
20 million cell in three injection plus filler
Other Name: cell and gel
Placebo Comparator: Plasebo
Injection of filler alone
Biological: Placebo
Injection of filler and cell carrier media
Other Name: Control

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01115634

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Principal Investigator: Saeed Shafiyan, MD Royan Institute
Study Director: Nasser Aghdami, MD., PhD Royan Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Hamid Gourabi, Royan institute
ClinicalTrials.gov Identifier: NCT01115634     History of Changes
Other Study ID Numbers: Royan-skin-002
Study First Received: May 1, 2010
Last Updated: July 14, 2011
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Fibroblast
Cell transplantation
Facial deformities

ClinicalTrials.gov processed this record on September 30, 2014