Transplantation of Fibroblast for Correction of Nasolabial Folds

Skin Aging Clinical Trial

Official title:

Autologous Transplantation of Cultured Fibroblast for Correction of Nasolabial Folds

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03140319
• Other study ID #: SCARM-Skin-001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 10, 2020
• Est. completion date: December 26, 2021

Study information

• Verified date: July 2020
• Source: SCARM Institute, Tabriz, Iran
• Contact: Peyman Keyhanvar, MD, Ph.D
• Phone: 0914 114 6863
• Email: drkeyhanvar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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%

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 26, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 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)

Related Conditions & MeSH terms

• Nasolabial Folds
• Skin Aging

Intervention

Biological:
• Fibroblast
Transplantation of 20 million cell by three injection
• Placebo
Injection of Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Stem cell and Regenerative Medicine institute (SCARM)	Tabriz

Sponsors (1)

Lead Sponsor	Collaborator
SCARM Institute, Tabriz, Iran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (4)

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: — View Citation

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 repla — View Citation

Rigotti G, Charles-de-Sá 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 Rejuvenatio — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correction of Nasolabial	Evaluate the correction of skin changes after transplantation of autologous fibroblasts by medical examination	6 months after transplantation