NCT01115634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

July 21, 2016

Status Verified

May 1, 2010

Enrollment Period

7 years

First QC Date

May 1, 2010

Last Update Submit

July 20, 2016

Conditions

Nasolabial FoldsGlabellar CreaseDeep Wrinkles of the ForeheadAcne Scars

Keywords

FibroblastCell transplantationFacial deformities

Outcome Measures

Primary Outcomes (1)

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

    6 months

Study Arms (1)

Fibroblast

EXPERIMENTAL

Injection of autologous cultured fibroblast

Biological: FibroblastBiological: fibroblast and gel

Interventions

FibroblastBIOLOGICAL

20 million cell in three injection

Also known as: cell alone
Fibroblast
fibroblast and gelBIOLOGICAL

20 million cell in three injection plus filler

Fibroblast

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Available and willing to attend all follow-up visits.
  • Age \> 18 years.
  • Able and willing to give informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Tehran Province, Iran

Location

Related Publications (2)

  • 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.

    PMID: 31606971DERIVED

  • 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.

    PMID: 31606970DERIVED

Related Links

MeSH Terms

Interventions

CarboxylesteraseGels

Intervention Hierarchy (Ancestors)

Carboxylic Ester HydrolasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Saeed Shafiyan, MD

    Royan Institute

    PRINCIPAL INVESTIGATOR

  • Nasser Aghdami, MD., PhD

    Royan Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2010

First Posted

May 4, 2010

Study Start

September 1, 2008

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

July 21, 2016

Record last verified: 2010-05

Locations

IR(1)