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

Phase 2

• Conditions: Neurotrophic Ulcers; Burns
• Interventions: Biological: study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions

• 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

Arm && Interventions

Group	Intervention	Description
cell therapy	study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions	study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions

Primary Outcome Measures

Name	Time	Method
efficiency	six weeks

Trial Locations

Locations (1)

Ural State Medical Academy; 🇷🇺 Ekaterinburg, Russian Federation