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Autologous Fibroblast Transplantation in Facial Deformities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01115634
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : July 21, 2016
Information provided by (Responsible Party):
Royan Institute

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.

Condition or disease Intervention/treatment Phase
Nasolabial Folds Glabellar Crease Deep Wrinkles of the Forehead Acne Scars Biological: Fibroblast Biological: fibroblast and gel Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Transplantation of Cultured Fibroblast for Facial Contour Deformities
Study Start Date : September 2008
Actual Primary Completion Date : September 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: Fibroblast
Injection of autologous cultured fibroblast
Biological: Fibroblast
20 million cell in three injection
Other Name: cell alone

Biological: fibroblast and gel
20 million cell in three injection plus filler

Primary Outcome Measures :
  1. 2-point shift in at least one treated area using a standardized 7-point photoguide [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01115634

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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
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Principal Investigator: Saeed Shafiyan, MD Royan Institute
Study Director: Nasser Aghdami, MD., PhD Royan Institute
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Royan Institute Identifier: NCT01115634    
Other Study ID Numbers: Royan-skin-002
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: May 2010
Keywords provided by Royan Institute:
Cell transplantation
Facial deformities
Additional relevant MeSH terms:
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Congenital Abnormalities