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

Phase 2

• Conditions: Neurotrophic Ulcers; Burns

• Registration Number: NCT01884831
• Lead Sponsor: Ural State Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-24
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-12
• Study Start: 2014-02
• Primary Completion: 2017-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
efficiency	six weeks

Trial Locations

Locations (1)

Ural State Medical Academy; 🇷🇺 Ekaterinburg, Russian Federation