Autologous Fibroblast Transplantation in Facial Deformities

July 20, 2016 updated by: Royan Institute

Autologous Transplantation of Cultured Fibroblast for Facial Contour Deformities

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fibroblast
Injection of autologous cultured fibroblast
Biological: Fibroblast
20 million cell in three injection
Other Names:
  • cell alone
Biological: fibroblast and gel
20 million cell in three injection plus filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2-point shift in at least one treated area using a standardized 7-point photoguide
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Investigators

  • Principal Investigator: Saeed Shafiyan, MD, Royan Institute
  • Study Director: Nasser Aghdami, MD., PhD, Royan Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

May 1, 2010

First Submitted That Met QC Criteria

May 1, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan-skin-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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