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Autologous Fibroblast Transplantation in Facial Deformities

Primary Purpose

Nasolabial Folds, Glabellar Crease, Deep Wrinkles of the Forehead

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Fibroblast
fibroblast and gel
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasolabial Folds focused on measuring Fibroblast, Cell transplantation, Facial deformities

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royan Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fibroblast

Arm Description

Injection of autologous cultured fibroblast

Outcomes

Primary Outcome Measures

2-point shift in at least one treated area using a standardized 7-point photoguide

Secondary Outcome Measures

Full Information

First Posted
May 1, 2010
Last Updated
July 20, 2016
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01115634
Brief Title
Autologous Fibroblast Transplantation in Facial Deformities
Official Title
Autologous Transplantation of Cultured Fibroblast for Facial Contour Deformities
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasolabial Folds, Glabellar Crease, Deep Wrinkles of the Forehead, Acne Scars
Keywords
Fibroblast, Cell transplantation, Facial deformities

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibroblast
Arm Type
Experimental
Arm Description
Injection of autologous cultured fibroblast
Intervention Type
Biological
Intervention Name(s)
Fibroblast
Other Intervention Name(s)
cell alone
Intervention Description
20 million cell in three injection
Intervention Type
Biological
Intervention Name(s)
fibroblast and gel
Intervention Description
20 million cell in three injection plus filler
Primary Outcome Measure Information:
Title
2-point shift in at least one treated area using a standardized 7-point photoguide
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saeed Shafiyan, MD
Organizational Affiliation
Royan Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD., PhD
Organizational Affiliation
Royan Institute
Official's Role
Study Director
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31606971
Citation
Salehi Z, Shams-Ghahfarokhi M, Razzaghi-Abyaneh M. Internal Transcribed Spacer rDNA and TEF-1alpha Gene Sequencing of Pathogenic Dermatophyte Species and Differentiation of Closely Related Species Using PCR-RFLP of The Topoisomerase II. Cell J. 2020 Apr;22(1):85-91. doi: 10.22074/cellj.2020.6372. Epub 2019 Sep 8.
Results Reference
derived
PubMed Identifier
31606970
Citation
Bajouri A, Orouji Z, Taghiabadi E, Nazari A, Shahbazi A, Fallah N, Mohammadi P, Rezvani M, Jouyandeh Z, Vaezirad F, Khalajasadi Z, Ghasemi M, Fanni A, Haji Hosseinali S, Alizadeh A, Baharvand H, Shafieyan S, Aghdami N. Long-Term Follow-up of Autologous Fibroblast Transplantation for Facial Contour Deformities, A Non-Randomized Phase IIa Clinical Trial. Cell J. 2020 Apr;22(1):75-84. doi: 10.22074/cellj.2020.6340. Epub 2019 Sep 8.
Results Reference
derived
Links:
URL
http://www.royaninstitute.org
Description
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Autologous Fibroblast Transplantation in Facial Deformities

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