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Status unknownNCT03140319Updated Oct 27, 2020

Transplantation of Fibroblast for Correction of Nasolabial Folds

A Phase 1/2 interventional study of Fibroblast and Placebo in Nasolabial Folds and Skin Aging, sponsored by SCARM Institute, Tabriz, Iran. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-27.

Sponsored by SCARM Institute, Tabriz, Iran · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

Autologous cultured fibroblast which is obtain from the patient's normal skin is harvested and expanded in an in vitro. Biopsies samples are obtained from the behind of the patient's ear as a source of fibroblasts, then fibroblast cells isolated and expanded through cell culture, and used for the correction of Nasolabial folds, deep wrinkles of the forehead. Prior to final packaging, cell viability is assessed to be at least 85%

02

Conditions studied

  • Nasolabial Folds
  • Skin Aging

Keywords

  • Fibroblast
  • Cell transplantation
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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)
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Fibroblast

    Injection of Fibroblast

    Biological: Fibroblast

  • Placebo comparator
    Placebo

    the patient receive placebo injection

    Biological: Placebo

Interventions

  • BiologicalFibroblast

    Transplantation of 20 million cell by three injection

    Also known as: Autologous injection of Fibroblast

  • BiologicalPlacebo

    Injection of Placebo

05

What researchers measure

Primary outcomes

  1. Correction of Nasolabial

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

    Time frame: 6 months after transplantation

06

Study locations

1 site
  • Stem cell and Regenerative Medicine institute (SCARM)
    Tabriz, Iran, Islamic Republic of
    • Peyman Keyhanvar, Ph.D · Contact
    • Neda Keyhanvar, Ph.D · Sub investigator
07

References and documents

Publications

  • 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. PubMed 17338681 ↗
  • 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. PubMed 23566237 ↗
  • 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. PubMed 9063788 ↗
  • 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. PubMed 26879294 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03140319
Lead sponsor
SCARM Institute, Tabriz, Iran
Responsible party
Sponsor
First posted
May 4, 2017
Start date
Dec 10, 2020 (estimated)
Primary completion
Nov 15, 2021 (estimated)
Completion
Dec 26, 2021 (estimated)
Last update
Oct 27, 2020

Study contacts

Peyman Keyhanvar, MD, Ph.D
Contact
drkeyhanvar@gmail.com
0914 114 6863
Peyman Keyhanvar, MD, Ph.D
study director · Deputy for translational medicine of SCARM institute
Mohammad Nouri, Ph.D
study chair · Head of SCARM institute
Raheleh Farahzadi, Ph.D
principal investigator · cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran
Samira Asghari, MSc
principal investigator · SCARM institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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