NCT03140319

Brief Summary

The study evaluated the safety and efficacy of the Autologous cultured fibroblast for correction of Nasolabial folds and inhibition of skin aging

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
3.6 years until next milestone

Study Start

First participant enrolled

December 10, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2021

Completed
Last Updated

October 27, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

May 2, 2017

Last Update Submit

October 24, 2020

Conditions

Nasolabial FoldsSkin Aging

Keywords

FibroblastCell transplantation

Outcome Measures

Primary Outcomes (1)

  • Correction of Nasolabial

    Evaluate the correction of skin changes after transplantation of autologous fibroblasts by medical examination

    6 months after transplantation

Study Arms (2)

Fibroblast

EXPERIMENTAL

Injection of Fibroblast

Biological: Fibroblast

Placebo

PLACEBO COMPARATOR

the patient receive placebo injection

Biological: Placebo

Interventions

FibroblastBIOLOGICAL

Transplantation of 20 million cell by three injection

Also known as: Autologous injection of Fibroblast
Fibroblast
PlaceboBIOLOGICAL

Injection of Placebo

Placebo

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 any cellular products
  • 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, hepatitis B virus (HBV), hepatitis C virus (HCV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stem cell and Regenerative Medicine institute (SCARM)

Tabriz, Iran

Location

Related Publications (4)

  • Weiss RA, Weiss MA, Beasley KL, Munavalli G. Autologous cultured fibroblast injection for facial contour deformities: a prospective, placebo-controlled, Phase III clinical trial. Dermatol Surg. 2007 Mar;33(3):263-8. doi: 10.1111/j.1524-4725.2007.33060.x.

    PMID: 17338681RESULT

  • Munavalli GS, Smith S, Maslowski JM, Weiss RA. Successful treatment of depressed, distensible acne scars using autologous fibroblasts: a multi-site, prospective, double blind, placebo-controlled clinical trial. Dermatol Surg. 2013 Aug;39(8):1226-36. doi: 10.1111/dsu.12204. Epub 2013 Apr 8.

    PMID: 23566237RESULT

  • Purdue GF, Hunt JL, Still JM Jr, Law EJ, Herndon DN, Goldfarb IW, Schiller WR, Hansbrough JF, Hickerson WL, Himel HN, Kealey GP, Twomey J, Missavage AE, Solem LD, Davis M, Totoritis M, Gentzkow GD. A multicenter clinical trial of a biosynthetic skin replacement, Dermagraft-TC, compared with cryopreserved human cadaver skin for temporary coverage of excised burn wounds. J Burn Care Rehabil. 1997 Jan-Feb;18(1 Pt 1):52-7. doi: 10.1097/00004630-199701000-00009.

    PMID: 9063788RESULT

  • Rigotti G, Charles-de-Sa L, Gontijo-de-Amorim NF, Takiya CM, Amable PR, Borojevic R, Benati D, Bernardi P, Sbarbati A. Expanded Stem Cells, Stromal-Vascular Fraction, and Platelet-Rich Plasma Enriched Fat: Comparing Results of Different Facial Rejuvenation Approaches in a Clinical Trial. Aesthet Surg J. 2016 Mar;36(3):261-70. doi: 10.1093/asj/sjv231.

    PMID: 26879294RESULT

Study Officials

  • Peyman Keyhanvar, MD, Ph.D

    Deputy for translational medicine of SCARM institute

    STUDY DIRECTOR

  • Mohammad Nouri, Ph.D

    Head of SCARM institute

    STUDY CHAIR

  • Raheleh Farahzadi, Ph.D

    cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran

    PRINCIPAL INVESTIGATOR

  • Samira Asghari, MSc

    SCARM institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peyman Keyhanvar, MD, Ph.D

CONTACT

0914 114 6863drkeyhanvar@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 4, 2017

Study Start

December 10, 2020

Primary Completion

November 15, 2021

Study Completion

December 26, 2021

Last Updated

October 27, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)