The Study of the Effectiveness of Tissue Equivalent on the Basis of Cultured Cells to Heal Skin Blemishes

Burns Clinical Trial

— SETES  

Official title:

Phase 2 The Use of Tissue-equivalent Based on Cultured Cells for Healing Skin Blemishes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01884831
• Other study ID #: USMA01082012
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 19, 2013
• Last updated: December 10, 2013
• Start date: February 2014
• Est. completion date: July 2018

Study information

• Verified date: December 2013
• Source: Ural Medical University
• Contact: Arteom V Korotkov
• Phone: +73432421546
• Email: larim[@]mail.ru
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

In Russia the treatment nonhealing skin defects often limited to surgical interventions, despite having developed modern methods of treatment of non-healing ulcers and other skin imperfections. During the many years of research we have developed a skin equivalent comprising living cells.

During pilot trial showed that the skin equivalent provides healing skin defect within 1-4 weeks in 95% of patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1
• Est. completion date: July 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• The presence of non-healing ulcer at least a month, an area of not less than 3 cm2 or smaller area of deep defects;

• Availability of burns II or III level;

• Epidermolysis bullosa;

• Availability of post-burn scars

• Defects in the skin after surgery

Exclusion Criteria:

• Acute and chronic diseases in the acute stage;

• Autoimmune diseases of connective tissue (collagen);

• Immunodeficiency states;

• System of inflammatory diseases of the skin;

• Conduct an aggressive corticosteroid therapy;

• Acute coronary syndrome;

• Acute disorders of cerebral circulation;

• Availability of local inflammation in the acute stage;

• Pregnancy;

• Breast-feeding.

• Positive results of the following tests: Anti-HIV-1 and -2, HIV-1Ag, anti-HTL VI and-II, anti-HbcorAg, HBs-Ag, anti-HCV, anti-CMV, anti-Toxoplasma gondii, RW, Neisseria gonorrheae, Chlamydia.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Neurotrophic Ulcers

Intervention

Biological:
• study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions

Locations

Country	Name	City	State
Russian Federation	Ural State Medical Academy	Ekaterinburg

Sponsors (1)

Lead Sponsor	Collaborator
Ural Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficiency		six weeks	Yes