Autologous Fibroblast Transplantation in Facial Deformities

Nasolabial Folds Clinical Trial

Official title:

Autologous Transplantation of Cultured Fibroblast for Facial Contour Deformities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115634
• Other study ID #: Royan-skin-002
• Status: Completed
• Phase: Phase 2
• First received: May 1, 2010
• Last updated: July 20, 2016
• Start date: September 2008
• Est. completion date: November 2015

Study information

• Verified date: May 2010
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Scars
• Congenital Abnormalities
• Deep Wrinkles of the Forehead
• Glabellar Crease
• Nasolabial Folds

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-point shift in at least one treated area using a standardized 7-point photoguide		6 months	Yes

External Links

•   Link
•   The Royan cell therapy center site for education